Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Testicular Neoplasms

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Patients with disseminated testicular cancer

the DEXA scan to measure bone and fat will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.

The patients in the longitudinal part of the study will have a DEXA scan at baseline, 1 month after the end of chemotherapy and after 1 year.

Dexa scan

the audiogram will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.

The patients in the longitudinal part of the study will have an audiogram at baseline, 1 month after the end of chemotherapy and after 1 year.

audiogram

the measurements (continuous assessment of heart rate and blood pressure using an non-invasive Finapress device) during 30 minutes will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.

The patients in the longitudinal part of the study will have those measurements taken at baseline, 1 month after the end of chemotherapy and after 1 year.

measurement of heart rate variability and baroreflex sensitivity

Glucose tolerance will be assessed by drinking glucose water and measuring glucose at baseline and 2 hours later. It will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.

The patients in the longitudinal part of the study will have an assessment at baseline, 1 month after the end of chemotherapy and after 1 year.

Glucose tolerance assessment

a set of 10 Oral Nutrition Supplements (ONS) will be offered combined with a questionnaire to measure appreciation and preference for these food products. All these tests and questionnaires will be performed longitudinally (before the first chemotherapy, on day 7 of the first course, before the second course, on day 7 of the second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy) and cross-sectional (1, 3, 5 and 7 years after chemotherapy).

oral nutrition supplements

Two day food records will be used to investigate the actual dietary intake before the first and second course, during (on day 5 and 6) first and second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy.

Two day food records

A Food Frequency Questionnaire (FFQ) will be used to investigate the usual dietary intake before the start of the first course, before and after the second course, 1 month after start of the last course, seven months after the start of chemotherapy, and 1 year after the start of chemotherapy (longitudinal), and 1, 3, 5 and 7 years after chemotherapy (cross-sectional).

Food Frequency Questionnaire

A KL Reyners, MD, PhD

Taste and smell abnormalities are common in cancer patients undergoing chemotherapy, with a prevalence ranging from 46% to 77% for taste changes, and 35% to 75% for smell changes. These chemosensory changes are distressing for patients and can lead to changes in appetite, food choice, and nutrient intake. These changes can result in malnutrition and weight loss. Possibly, also unhealthy eating patterns can be developed due to these taste and smell changes, given the high prevalence of obesity among survivors of certain cancer types. The primary objective is to investigate the nature, prevalence, and duration of taste and smell changes in patients with disseminated testicular cancer treated with cisplatin based chemotherapy.

Rationale: Taste and smell abnormalities are common in cancer patients undergoing chemotherapy, with a prevalence ranging from 46% to 77% for taste changes, and 35% to 75% for smell changes. These chemosensory changes are distressing for patients and can lead to changes in appetite, food choice, and nutrient intake. These changes can result in malnutrition and weight loss. Possibly, also unhealthy eating patterns can be developed due to these taste and smell changes, given the high prevalence of obesity among survivors of certain cancer types. Objective: The primary objective is to investigate the nature, prevalence, and duration of taste and smell changes in patients with disseminated testicular cancer treated with cisplatin based chemotherapy. Secondary objectives are to explore the short- and long-term consequences of these chemosensory changes for (medical) food preference, dietary intake and quality of life, and to investigate the appreciation of medical food products in these testicular cancer patients. Furthermore, it will be assessed whether changes in taste and smell are related to the metabolic syndrome, and whether chemotherapy induced neurotoxicity is related to changes in taste and smell. Study design: The present study will have a longitudinal (with measurements before the first chemotherapy, on day 7 of the first course, before the second course, on day 7 of the second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy) and a cross-sectional (with measurements 1, 3, 5 and 7 years after chemotherapy) design. Patients can start participation in this study before the start of their chemotherapy, which will result in longitudinal data of these patients or they can start participation years after treatment, resulting in cross-sectional data.

Study population: Patients with disseminated testicular cancer treated with cisplatin based chemotherapy. This group is selected, because of the young age at diagnosis, the emetogenic chemotherapy treatment, the high survival rate, the increase in body mass index (BMI) and risk of cardiovascular disease in the long-term.

Intervention: Gustatory function will be tested using filter-paper taste strips to measure recognition thresholds for sweet, salty, sour and bitter taste. Olfactory function will be tested using Sniffin' Sticks to measure odor threshold, discrimination and recognition.

Besides, patients have to fill out questionnaires to assess taste and smell subjectively and to assess QoL. Food preference will be investigated by showing standardized photographs of sweet and savory food products, varying in fat and protein content. In addition, a set of 10 Oral Nutrition Supplements (ONS) will be offered combined with a questionnaire to measure appreciation and preference for these food products. All these tests and questionnaires will be performed longitudinally (before the first chemotherapy, on day 7 of the first course, before the second course, on day 7 of the second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy) and cross-sectional (1, 3, 5 and 7 years after chemotherapy). Two day food records will be used to investigate the actual dietary intake before the first and second course, during (on day 5 and 6) first and second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy. A Food Frequency Questionnaire (FFQ) will be used to investigate the usual dietary intake before the start of the first course, before and after the second course, 1 month after start of the last course, seven months after the start of chemotherapy, and 1 year after the start of chemotherapy (longitudinal), and 1, 3, 5 and 7 years after chemotherapy (cross-sectional).

A Dual Energy X-ray Absortiometrys (DEXA) scan will be used to get insight in possible changes in bone and fat mass during and after chemotherapy. To detect a possible cause of taste and smell changes, audiogram will be performed (to measure cisplatin induced neurotoxicity), and the baroreflex sensitivity (BRS) (to measure the quality of shortterm blood pressure maintenance), the blood glucose tolerance, insulin resistance, and DNA for SNP analysis will be collected. The DEXA scan, audiogram, BRS test, and blood glucose tolerance test will be performed before the first course of chemotherapy, one month after start of the last course, 1 year after the start of chemotherapy (longitudinal part), and 1, 3, 5 and 7 years after chemotherapy (cross-sectional part). A blood sample for DNA analysis will be taken at the start of the chemotherapy (longitudinal part), and 1, 3, 5 and 7 years after chemotherapy (cross-sectional part).

Taste, Smell and Chemotherapy (TASTY)

Taste and Smell Changes in Testicular Cancer Patients Treated With Cisplatin Based Chemotherapy

To investigate the nature, prevalence, and duration of taste and smell changes in patients with disseminated testicular cancer treated with cisplatin based chemotherapy (BEP (Bleomycin, Etoposide, cisPlatin) or EP (Etoposide, cisPlatin)).

Tests used are: Gustatory function will be tested using filter-paper taste strips to measure recognition thresholds for sweet, salty, sour and bitter taste. Olfactory function will be tested using Sniffin' Sticks to measure odor threshold, discrimination and recognition.

To explore the short- and long-term consequences of taste and smell changes in relation to food preference, dietary intake, and quality of life. Tests used: QoL questionnaires (EORTC QLQ-C30). Two day food records will be used to investigate the actual dietary intake before the first and second course, during (on day 5 and 6) first and second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy. A Food Frequency Questionnaire (FFQ) will be used to investigate the usual dietary intake.

To investigate the appreciation of medical food products in patients with disseminated testicular cancer treated with cisplatin based chemotherapy.

A set of 10 Oral Nutrition Supplements (ONS) will be offered combined with a questionnaire to measure appreciation and preference for these food products.

Food preference will be investigated by showing standardized photographs of sweet and savory food products, varying in fat and protein content.

To assess whether changes in taste and smell are related to the metabolic syndrome.

Tests used: glucose tolerance test and DEXA scan.

To assess whether chemotherapy induced neurotoxicity is related to changes in taste and smell.

TEsts used: audiogram, assessment of heart rate variability and baroreflex sensitivity.

University Medical Center Groningen

Antiemetics

Gastrointestinal Agents

Dimenhydrinate

Participants' body composition will be estimated using a SOZO device at 5 different time points over 12 weeks. Participant will also complete questionnaires and physical assessments during each study visit. These include waist \& hip measurements, weight/BMI, brief fatigue inventory, timed up and go test, 6 minute walk test, cancer distress assessment, ECOG performance status, hand grip strength test, and 3-day food diary. DEXA scans will be performed before treatment and after completion of treatment. Moving On assessments will be performed at first and last study visits.

Participants' body composition will be estimated using a SOZO device at 5 different time points over 12 weeks. Participant will also complete questionnaires and physical assessments during each study visit. These include waist \& hip measurements, weight/BMI, brief fatigue inventory, timed up and go test, 6 minute walk test, cancer distress assessment, ECOG performance status, hand grip strength test, and 3-day food diary. DEXA scans will be performed at first and last study visits.

SOZO device will estimate fluid status, total body composition, metabolic report, skeletal muscle mass, phase angle, body mass index, weight, and hydration index analysis. Participants will be asked to fast for at least 8 hours before each visit, but water may be consumed to ensure they are well-hydrated. Participants will be asked to provide a urine sample at each visit and to report the color of your urine to the staff so they can determine how well hydrated the participants are. If not hydrated to the extent needed, participants will be asked to drink water and repeat the urine sample again after 30 minutes. A total of 5 SOZO measurements will be recorded over 12 weeks.

SOZO Device

DEXA scan bone density reading with hip and spine measurements as well as a whole body composition scan will be performed. Where DEXA cannot be collected on the same day as other study assessments, Weight/BMI, Urine Color, and SOZO should all be collected (or repeated if already done) to coincide with the DEXA scan if SOZO is available at DEXA location.

DEXA Scan

Larry Gluck, MD

The purpose of this study is to assess how bone density and body composition changes after a cancer patient completes treatment and through 12-weeks post-treatment. Patients who enroll in the 12-week exercise program, Moving On, and those that do not elect to participate in the Moving On program will both be tracked, with assessments including SOZO measurements, DEXA scan (bone density and whole body composition), performance status tests, food log, urine color test, and other study assessments.

This is an observational, prospective, parallel-arm device use study. 50 subjects will be enrolled in the study. The study will look at the changes in the participants body composition post cancer treatment using the SOZO device. The SOZO device is intended to estimate the following body composition parameters: Fluid status (TBW, ECF, ICF), Total body composition (fat free mass, fat mass, % of weight), Metabolic report (active tissue mass, extracellular mass, basal metabolic rate), Skeletal muscle mass, Phase angle, Body mass index (BMI), Weight, and Hydration index (Hy-Dex) analysis. Participants will have 5 study visits during 12 weeks where SOZO measurements will be taken as well as other study measurements.

Body Composition Post Cancer Treatment

Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device

Change from baseline in body composition measures (intracellular fluid, extracellular fluid, fat mass, fat free mass, skeletal muscle mass, phase angle, and hydration index)

Evaluate patient general health using physical performance tests

Assess correlation of SOZO measurements with 3-day food recall.

Assess correlation of SOZO measurements and DEXA scan (bone density with hip and spine measurements and whole body composition) results.

Assess correlation of SOZO measurements with standard of care measurements.

Change from baseline in Brief Fatigue Inventory score

Change from baseline in Suscro Distress Inventory score

Assess correlation of SOZO measurements with urine color test.

ImpediMed Limited

Prisma Health-Upstate

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Prostatic Neoplasms

Breast Neoplasms

Inflammation

DEXA scan will be carried out 1 to 30 days prior to mastectomy. Patients will also complete the Godin Leisure Time Exercise Questionnaire (GLTEQ) and their waist to hip ratio will be measured.

DEXA scan will be carried out 1 to 30 days prior to radical prostatectomy. Patients will also complete the Godin Leisure Time Exercise Questionnaire (GLTEQ) and their waist to hip ratio will be measured.

Godin Leisure Time Exercise Questionnaire (GLTEQ)

Neil Iyengar, MD

The investigators want to find a better way to predict the risk of having fatty tissue inflammation by using a different approach to finding out body fat composition. In this study, the investigators want to estimate the body fat composition using a DEXA scan. DEXA stands for dual energy X-ray absorptiometry. It is the standard and established test to determine bone mineral density (how strong the bones are) to diagnose osteoporosis. This test can also be used to determine the body composition including percent body fat and lean mass. The investigators will compare the participants DEXA scan results for body fat composition to the inflammation found in the breast tissue from the mastectomy to see if there is a relationship. If successful, this may help us predict which patients may be at risk for breast cancer in the future. In addition, the investigators will compare the participants DEXA scan results for body fat composition and inflammation found in the fat tissue from the mastectomy or prostatectomy to the level of exercise activity as measured by a short questionnaire to see if there is a relationship. The investigators will also measure the participants waist to hip ratio.

Finally, at the time the participant has blood drawn for their standard presurgical testing, the investigators will also test the blood for prediabetes using a blood test called hemoglocin A1c. The investigators will also measure for the participants waist to hip ratio, and a Hgb A1c blood drawn will be take at the time of presurgical testing. If not feasible, Hgb A1c can be drawn at a separate visit prior to the DEXA scan. If successful, this may help us predict which patients may be at risk for breast cancer in the future.

Body Composition and White Adipose Tissue Inflammation

Weill Medical College of Cornell University

Memorial Sloan Kettering Cancer Center

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Wasting Syndrome

Cachexia

Syndrome

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Quality of Life

Fluorodeoxyglucose F18

Radiopharmaceuticals

20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC), or pancreatic cancer with documented cachexia.

20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC) or pancreatic cancer without cachexia.

18F-FDG PET will be compared with Dexa Scan result within and between arms.

18F-FDG PET + Dexa Scan

Jodie Palmer, PhD

Fiona Scott

Lee Sze Ting, MBBS, PhD

Hui Gan

Andrew Scott

Sze Ting Lee

Andrew M Scott, MD

This is a pilot trial using 18F-FDG PET and DXA scans to determine whether these investigations are objective tools to assess cachexia.

This pilot study will establish the differences in BAT uptake of 18F-FDG in cachectic and non-cachectic cancer patients using PET imaging.

Patients willbe assessed for sarcopenia using a dual energy X-ray absorptiometry or bone densitometry scan (DXA). Given the variables which may affect uptake of BAT in cancer patients, this study will standardise patient preparation and PET scan procedure in order to obtain the most reliable assessment of BAT activity in all patients on study.

It is hypothesisd that use of this PET imaging technique, which is part of standard care to assess cancer progression, may assist clinicians in early identification of metabolic changes in a patient, with potential for early intervention and utility in monitoring success of treatments of cachexia.

A total of 40 patients will be evaluated, 20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC) or pancreatic cancer without cachexia, and 20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC), or pancreatic cancer with documented cachexia, all of whom are referred for standard of care 18F-FDG PET scans.

20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC) or pancreatic cancer without cachexia, and 20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC), or pancreatic cancer with documented cachexia

Medical Imaging of Cachexia

A Pilot Bioimaging Trial of Cancer Cachexia

Cohort data will be shared via journal and conference presentations

Quantitation of the metabolic activity of brown adipose tissue, bone density and muscle mass using 18F-FDG uptake and bone densitometry will be correlated with a diagnosis of clinical cachexia.

Optimization of the patient environment (ie. ambient temperature) and metabolic state (ie. Heart rate, dietary state) to minimize the impact of these factors and allow direct comparison of metabolic activity of brown adipose tissue between cachectic and non-cachectic patients.

To validate change from normal laboratory range of inflammatory blood based proteins and enzymes in cachectic vs non-cachectic patients.

To validate change from normal laboratory range immune blood based proteins and enzymes in cachectic vs non-cachectic patients.

La Trobe University

Austin Health

Olivia Newton-John Cancer Research Institute

Heart and Blood Diseases

Substance Related Disorders

Wounds and Injuries

Cardiotoxicity

Metabolic Syndrome

Insulin Resistance

Hyperinsulinism

Glucose Metabolism Disorders

Breast Diseases

Skin Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Central Nervous System Depressants

Hypoglycemic Agents

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Anesthetics

Insulin

Insulin, Globin Zinc

Hormones

Chrysarobin

Bilirubin

Examination of participants prior to chemotherapy. Venous occlusion plethysmography SphygmoCor 24hour blood pressure DEXA scan Laboratory blood samples

Examination of participants immediately after chemotherapy. Venous occlusion plethysmography SphygmoCor 24hour blood pressure DEXA scan Laboratory blood samples

Examination of participants one year after chemotherapy. Venous occlusion plethysmography SphygmoCor 24hour blood pressure DEXA scan Laboratory blood samples

To characterize endothelial function in vivo the effect of vasodilatating substances is measured in the forearm circuit. The substances is administered via a thin catheter placed in the Brachial artery near the elbow in local anesthesia. Once the vessels dilate, the blood flow in the forearm will increase and the flow change is a measure of the vasodilatory capacity of that substance. The change is measured with classical venous occlusion plethysmography. The method described is established at Aarhus University Hospital and has been used for several decades to illustrate the effect of vasoactive drugs on the human circulation, meaning it is a proven and well documented method.

Venous occlusion plethysmography

Applanation tonometry (pulse wave velocity and central blood pressure/arterial stiffness): The central blood pressure and the augmentation index is estimated from the shape of the radial pulse wave measured with a tonometer.

Pulse wave velocity (PWV) is calculated from the average difference between the pulse pressure wave measured with a tonometer and the R in an ECG recorded simultaneously.

SphygmoCor

24hour blood pressure

Measurements of body composition: Total body fat and fat free mass is measured by Dual Energy X-ray Absorptiometry (DEXA).

DEXA scan

Fasting blood tests are drawn from an antecubital placed catheter (albumin, ALAT/ASAT, alkaline phosphatase, bilirubin, gammaglutamyl transferase, coagulation factors, red and white blood cells, creatinin, potassium, sodium, fasting lipids, fasting glucose, hemoglobin A1C, insulin, sex hormones, von Willebrand factor, low grade inflammation markers, DNA and RNA for later analyses, including relevant coding genes).

Further more urine samples to determine possible systemic impact of cardiovascular disease.

We will create a biobank containing urine and blood samples from participants for future research, provided that the participant gives her permission.

Responsibility for the biobank lies with the project responsible physician, Anders Bonde Jensen.

Laboratory blood samples

Anders B. Jensen, Professor

Several cytotoxic regimens are related to endothelial cell damage and vascular toxicity. Endothelial dysfunction is implicated in the pathogenesis of all known cardiovascular diseases (CVD) and closely related to the metabolic syndrome. Both CVD and diabetes contributes importantly to total mortality and to breast cancer (BC) specific mortality.

In the epidemiological part of the project, the investigators will determine the prevalence and incidence of cardiovascular and metabolic morbidity/mortality in early BC patients compared to the Danish background population.

In the clinical part, the investigators will study the changes of endothelial function and metabolic parameters in BC patients receiving chemotherapy.

With increasing number of BC survivors, long-term consequences of curative cancer treatment should be studied. The investigators hypothesize that cytotoxic therapy worsens metabolic parameters possibly through endothelial dysfunction. If this is true, the next step will be to evaluate how strict metabolic control will affect prognosis.

1. Background

   During the past 30 years, survival of breast cancer patients has improved substantially due to earlier diagnosis, improved surgical techniques, introduction of new combination of chemotherapy, new hormonal treatment, introduction of targeted treatment, and refinement of radiation techniques. With increasing number of cancer survivors, which in part are reached by more aggressive treatment, more attention is presently being drawn to long-term consequences of curative cancer treatment.

   Comorbidity among breast cancer patients has been thoroughly studied over the past years. Previous research has however, primarily focused on prevalence of comorbidity at the time of the cancer diagnosis (manifest comorbidity) and less attention has been paid to studying latent comorbidity developing after the diagnosis, which can be a result of the treatment. Furthermore it is not known if the incidence of this later developed comorbidity is different in breast cancer patients compared to the general population. Additionally, most studies do not address specific diseases but focus on comorbidity as such. Emerging evidence, however, indicates that cardiovascular disease (CVD) (encompassing cerebrovascular disease manifested by stroke and TCI and coronary heart disease manifested by infarction, arrhythmias, heart failure and sudden death) and diabetes may play a pivotal role, because it contributes importantly both to total mortality and to breast cancer specific mortality among breast cancer survivors.

   Comorbidity at breast cancer diagnosis is an independent adverse prognostic factor. In Denmark, comorbidity was present in 26% of breast cancer patients diagnosed 2006-2008, and the presence of comorbidity increased the risk of dying from breast cancer as well as from other causes with adjusted hazard ratios for all-cause mortality of 1.45 and breast cancer-specific mortality 1.30. Most studies have, however, used a summary measure of comorbidity such as the Charlson Comorbidity Index Score, and only few studies have assessed the individual effects of specific comorbidities on the mortality among breast cancer patients. These few studies universally demonstrate that CVD and diabetes are associated with decreased overall survival. Thus, Patnaik et al showed that among breast cancer patients, women with the following comorbidities were more likely to die as a result of other causes: CVD (59.2%), COPD (52.2%), diabetes (47.8%) and previous cancer (43.8%) Fully adjusted relative hazards of the effects of comorbidities on breast cancer-specific mortality was 1.24 for CVD and 1.10 for diabetes, and among the total study population of breast cancer patients, CVD was the primary cause of death (15.9%), followed closely by breast cancer (15.1%). In a meta-analysis of studies of overall survival in breast cancer patients with preexisting diabetes, Barone et al found that preexisting diabetes was associated with an increased mortality with a hazard rate (HR) of 1.61; (95% CI, 1.46-1.78).

   Metabolic syndrome (MS) is a cluster of disorders including hypertension, type II diabetes, dyslipidemia and obesity, and certain aspects of the MS are well described in relation to breast cancer. It has been shown that obesity is associated with an increased risk of developing breast cancer among postmenopausal women, obese patients present with more advanced cancers, and women who are overweight or obese at the time of breast cancer diagnosis or gain weight after diagnosis are at increased risk of cancer recurrence and death compared with leaner women. One study have shown that the effects of adjuvant therapy is less in obese breast cancer patients. An association between diabetes and breast cancer has also been observed. Other components of the MS, including low HDL-cholesterol, high triglycerides, hypertension, and serum testosterone are, however, less well described, but may be associated with an increased breast cancer risk and a worse breast cancer prognosis. A recent study showed that patients with MS present with more aggressive tumors. In patients with metastatic disease, response to chemotherapy appears to be inferior when the patient is diagnosed with MS, as well. Emerging evidence suggest that the MS may be quite prevalent among patients with breast cancer.

   In our study the metabolic syndrome will be defined in accordance with the definition of the National Cholesterol Education Program (NCEP)/Adult Treatment Panel III (ATPIII). A diabetic FPG level is defined as FPG \>7 mmol/l; impaired fasting glycemia is defined as FPG between 6.1 and 7.0 mmol/l according to World Health Organization criteria.

   Endothelial cells line the internal lumen of all the vasculature and serve as an interface between circulating blood and vascular smooth muscle cells (VSMCs). Apart from being the key participant during the process of angiogenesis, these dynamic structures can actively regulate basal vascular tone and vascular reactivity in physiological and pathological conditions. They respond to mechanical forces and neurohumoral mediators by releasing a variety of relaxing and contracting factors such as nitric oxide (NO) and prostacyclin. The balance between the vasodilatation and vasoconstriction is maintained by the endothelium, and the disruption of this balance leads to endothelial dysfunction and causes damage to the arterial wall. Endothelial cells are also responsible for the maintenance of blood fluidity and restoration of vessel wall integrity (when injured) to avoid bleeding. Endothelial cell-derived factors are also critical mediators of VSMC growth and inflammation.

   Several cytotoxic regimens have been shown to cause endothelial cell damage and vascular toxicity by various mechanisms. Thus, anthracyclines and taxanes (which forms the cornerstone of breast cancer treatment) together with cytotoxics as alkylating agents, bleomycin, vinca alkaloids and antimetabolites have been associated with endothelial cell apoptosis, oxidative stress, inflammation, coagulation disorders/thrombotic state, endothelial cell proliferation-migration, effects on VEGF, and impaired endothelial-dependent vasodilation in vitro and in vivo, although the exact mechanisms are not known. Changes in endothelial function hasten the development of micro- and macro-angiopathy and endothelial dysfunction is an important surrogate marker of atherosclerotic activity. Endothelial dysfunction has been implicated in the pathogenesis and clinical course of all known cardiovascular diseases and is associated with future risk of adverse cardiovascular events.

   Endothelial dysfunction is closely related to the MS, and a deficiency of endothelial-derived NO is believed to be the primary defect that links insulin resistance and endothelial dysfunction. It is not known whether worsening of endothelial dysfunction aggravates elements of the MS.
2. Objective

The aim of this research program is to study the changes of endothelial function and metabolic parameters in patients receiving chemotherapy for early stage breast cancer, and to compare these parameters with healthy age matched controls.

Our theory is that cytotoxic therapy can induce endothelial cell damage and vascular toxicity causing endothelial dysfunction. The investigators believe that endothelial dysfunction is a mediator in the MS and predisposes to later cardiovascular disease, thus rendering patients receiving cytotoxic therapy at risk of these conditions.

The investigators hypothesize that:

1. Cytotoxic therapy induces endothelial dysfunction in predisposed early breast cancer patients.
2. Metabolic syndrome may be aggravated by cytotoxic therapy, possibly through worsening of endothelial dysfunction.
3. Treatment of early breast cancer (chemotherapy, antihormonal therapy and/or trastuzumab) aggravates preexisting CVD and/or metabolic disease and may induce the metabolic syndrome.

3) Methods

The study is a clinical case-control study with the inclusion of 90 patients divided into 3 groups as stated below. 30 healthy women with the same age will participate as controls (group 4).

Group 1: Newly diagnosed patients with early breast cancer. Investigated immediately prior to start of adjuvant therapy.

Group 2: Early breast cancer patients, who have received standard treatment. Investigated immediately after completion of adjuvant chemotherapy.

Group 3: Early breast cancer patients, who have received standard treatment. Investigated 1 year after completed chemotherapy.

Group 4: Healthy, age-matched controls. Controls will be recruited from an internet resource (www.forsoegsperson.dk):

The test program will consist of the following investigations:

1. To characterize endothelial function in vivo the effect of vasodilatating substances is measured in the forearm circuit. The substances is administered via a thin catheter placed in the Brachial artery near the elbow in local anesthesia. Once the vessels dilate, the blood flow in the forearm will increase and the flow change is a measure of the vasodilatory capacity of that substance. The change is measured with classical venous occlusion plethysmography. The method described is established at Aarhus University Hospital and has been used for several decades to illustrate the effect of vasoactive drugs on the human circulation, meaning it is a proven and well documented method.
2. Applanation tonometry (pulse wave velocity and central blood pressure/arterial stiffness): The central blood pressure and the augmentation index is estimated from the shape of the radial pulse wave measured with a tonometer.

   Pulse wave velocity (PWV) is calculated from the average difference between the pulse pressure wave measured with a tonometer and the R in an ECG recorded simultaneously.
3. Medical history: A full medical history including use of medication is obtained from every subject. Age, smoking status and concurrent medication. For patients tumor characteristics and anticancer treatment will also be described.
4. Clinical examination: A regular objective examination is performed including weight, height (BMI) and measurements of hip and waist circumference.
5. Measurements of body composition: Total body fat and fat free mass is measured by Dual Energy X-ray Absorptiometry (DEXA).
6. Electrocardiography: A conventional 12 lead surface electrocardiogram is recorded.
7. 24 hour blood pressure measurement
8. Laboratory tests: Fasting blood tests are drawn from an antecubital placed catheter (albumin, ALAT/ASAT, alkaline phosphatase, bilirubin, gammaglutamyl transferase, coagulation factors, red and white blood cells, creatinin, potassium, sodium, fasting lipids, fasting glucose, hemoglobin A1C, insulin, sex hormones, von Willebrand factor, low grade inflammation markers, DNA and RNA for later analyses, including relevant coding genes).

   Further more urine samples to determine possible systemic impact of cardiovascular disease.

   The investigators will create a biobank containing urine and blood samples from participants for future research, provided that the participant gives her permission.

   Responsibility for the biobank lies with the project responsible physician, Anders Bonde Jensen.
9. To characterize the overall risk of cardiovascular death within 10 years, the investigators will use a well- established and validated method called SCORE using age, gender, smoking status, systolic blood pressure and plasma cholesterol for risk stratification.
10. Every premenopausal woman will be asked about the possibility of her being pregnant. In case of doubt the investigators will do a pregnancy test (urine hcg)

Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium

P-Kolesterol, P-Kolesterol HDL, P-Kolesterol LDL, P-Triglyceride, P-Glukose, P-Progesteron, P-Testosteron, P-Von Willebrand-faktor, P-Natrium, P-Kalium, P-Kreatinin and P-Østradiol.

The SCORE-system is a well- established and validated method using age, gender, smoking status, systolic blood pressure and plasma cholesterol for risk stratification.

Danish Cancer Society

University of Aarhus

Participants' body composition will be estimated using a SOZO device at 5 different time points across their cancer treatment. Participant will also complete questionnaires and physical assessments during each study visit. These include waist \& hip measurements, weight/BMI, brief fatigue inventory, timed up and go test, cancer distress assessment, ECOG performance status, hand grip strength test, and 24-hour food recall. DEXA scans will be performed before treatment and after completion of treatment.

SOZO device will estimate fluid status, total body composition, metabolic report, skeletal muscle mass, phase angle, body mass index, weight, and hydration index analysis. SOZO measurements will be performed before the start of cancer treatment, at the 1/4, 1/2, and 3/4 time points of treatment, and after completion of treatment. Participants be asked to fast for at least 8 hours before each visit, but water may be consumed to ensure they are well-hydrated. Participants will be asked to provide a urine sample at each visit and to report the color of your urine to the staff so they can determine how well hydrated the participants are. If not hydrated to the extent needed, participants will be asked to drink water and repeat the urine sample again after 30 minutes.

The purpose of this study is to assess how bone density and body composition changes over a cancer patient's treatment via SOZO measurements, DEXA scan (bone density and whole body composition), performance status tests, food log, urine color test, and other study assessments. These assessments will begin after cancer diagnosis but prior to intervention, and continue during treatment and at post-treatment visits.

This is an observational, prospective device use study. 50 subjects will be enrolled in the study. The study will look at the changes in the participants body composition as they go through cancer treatment using the SOZO device. The SOZO device is intended to estimate the following body composition parameters: Fluid status (TBW, ECF, ICF), Total body composition (fat free mass, fat mass, % of weight), Metabolic report (active tissue mass, extracellular mass, basal metabolic rate), Skeletal muscle mass, Phase angle, Body mass index (BMI), Weight, and Hydration index (Hy-Dex) analysis. Participants will have 5 study visits during the course of their cancer treatment where SOZO measurements will be taken as well as other study measurements.

Body Composition During Cancer Treatment

Assessment of Body Composition During Cancer Treatment Using the SOZO Device

Assess change in body composition from baseline to final visit

Assess correlation of SOZO measurements with 24-hour food recall.

Assess correlation of SOZO measurements and DEXA scan (bone density with hip and spine measurements and whole body composition) results

Assess correlation of SOZO measurements with standard of care measurements

Change from baseline in 6 minute walk test distance

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Taste, Smell and Chemotherapy (TASTY)	NCT01641172	Testicular Canc...	Dexa scan audiogram measurement of ... Glucose toleran... oral nutrition ... Two day food re... Food Frequency ...	18 Years - 50 Years	University Medical Center Groningen
Taste, Smell and Chemotherapy (TASTY)	NCT01641172	Testicular Canc...	Dexa scan audiogram measurement of ... Glucose toleran... oral nutrition ... Two day food re... Food Frequency ...	18 Years - 50 Years	University Medical Center Groningen
Body Composition Post Cancer Treatment	NCT03690401	Cancer	SOZO Device DEXA Scan	18 Years -	Prisma Health-Upstate
Body Composition and White Adipose Tissue Inflammation	NCT02713022	Breast Cancer Prostate Cancer Body Compositio... White Adipose T...	DEXA Scan Godin Leisure T...	18 Years -	Memorial Sloan Kettering Cancer Center
Medical Imaging of Cachexia	NCT04127981	Cancer Cachexia	18F-FDG PET + D...	18 Years -	Olivia Newton-John Cancer Research Institute
Body Composition and White Adipose Tissue Inflammation	NCT02713022	Breast Cancer Prostate Cancer Body Compositio... White Adipose T...	DEXA Scan Godin Leisure T...	18 Years -	Memorial Sloan Kettering Cancer Center
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium	NCT02652975	Breast Neoplasm... Endothelial Dys... Cardiovascular ... Metabolic Syndr...	Venous occlusio... SphygmoCor 24hour blood pr... DEXA scan Laboratory bloo...	18 Years - 99 Years	University of Aarhus
Body Composition During Cancer Treatment	NCT03784911	Cancer	SOZO Device DEXA Scan	18 Years -	Prisma Health-Upstate
Body Composition Post Cancer Treatment	NCT03690401	Cancer	SOZO Device DEXA Scan	18 Years -	Prisma Health-Upstate
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium	NCT02652975	Breast Neoplasm... Endothelial Dys... Cardiovascular ... Metabolic Syndr...	Venous occlusio... SphygmoCor 24hour blood pr... DEXA scan Laboratory bloo...	18 Years - 99 Years	University of Aarhus
Body Composition Post Cancer Treatment	NCT03690401	Cancer	SOZO Device DEXA Scan	18 Years -	Prisma Health-Upstate
Medical Imaging of Cachexia	NCT04127981	Cancer Cachexia	18F-FDG PET + D...	18 Years -	Olivia Newton-John Cancer Research Institute

Spots Global Cancer Trial Database for dexa scan

Every month we try and update this database with for dexa scan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dexa scan

Every month we try and update this database with for dexa scan cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dexa scan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.