Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Behaviors and Mental Disorders

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Quality of Life

Consecutive patients referred for cytostatic treatment or in treatment with cytostatic agents for colorectal or pancreatic cancer

Bio Impedance Spectroscopy (BIS)

Jens R Andersen

An observational study of the relationship between fat free mass and toxicity of cytostatics in cancer patients, at the department of Clinical Oncology at Zealand University Hospital, Roskilde, Denmark. Fat free mass will be measured by bio impedance spectroscopy and data on toxicity will be obtained from medical records and interviews/questionnaires with the patients.

With a prospective observational design, this study will examine whether there is a correlation between the total dose of cytostatics per measured fat-free mass (FFM) (mg cytostatic agent/kg FFM) and toxicity of cytostatics among cancer patients. The study will include patients with a primary diagnosis of any stage colorectal or pancreatic cancer.

The hypothesis is, that a higher total dose of cytostatics per FFM will correlate to more frequent and/or more severe toxicity than a lower total dose. In extension to this, we hypothesize that a loss of FFM during treatment, and thereby an increased total dose of cytostatics per FFM, will lead to more frequent and severe toxicity.

Recruitment and data collection will take place at the department of Clinical Oncology at Zealand University Hospital, Roskilde over about a five month period. Each patient will be included for two-four cycles of cytostatic treatment. FFM will be measured by bio impedance spectroscopy as close to the first day of each cycle of cytostatic treatment as possible. Information about toxicity will be obtained from patient records and through interviews with the patients. Interviews will be conducted at day 5 (4-6) of each cycle and at the end of each cycle. The interviews include questionnaires about specific toxicities, using National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and overall health and quality of life, and 24-hour recall of dietary intake and questions about physical activity level.

In short, relevant outcomes are change in FFM, hematology, grade 3/4 hematological toxicity as defined by NCI CTCAE, dose-limiting toxicity, hospitalization, patient-reported adverse events, overall health and quality of life, and nutritional intake.

The Relationship Between Fat Free Mass and Toxicity of Cytostatics in Cancer Patients

Correlation between overall health, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, evaluated on a 7-point scale, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between overall quality of life, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, evaluated on a 7-point scale, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between relative fulfilment of energy requirement, and change therein, on day 5 (4-6) of a cycle or the last day of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg), and change in fat free mass (kg). Energy requirement is estimated by Harris-Benedict formula, including among other assessment of physical activity level. Energy intake is assessed by 24-hour recall of nutrition intake.

Correlation between relative fulfilment of protein requirement, and change therein, on day 5 (4-6) of a cycle or the last day of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg), and change in fat free mass (kg). Protein requirement is estimated from the Danish Health Authority´s recommendation for adult patients. Protein intake is assessed by 24-hour recall of nutrition intake.

Correlation between relative and absolute weight change, measured at the beginning of each cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg), and change in fat free mass (kg).

Correlation between patient reported severity and interference with daily activities of difficulty swallowing on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported severity and interference with daily activities of mouth/throat sores on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported severity of taste changes on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported severity and interference with daily activities of decreased appetite on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported frequency and severity of nausea on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported frequency and severity of vomiting on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported severity of constipation on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported frequency of diarrhea on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported severity and interference with daily activities of shortness of breath on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported incidence of rash (yes/no), and change therein, of the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported degree of hair loss on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported severity of hand-foot syndrome on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported severity and interference with daily activities of numbness and tingling on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported frequency, severity and interference with daily activities of general pain on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported severity and interference with daily activities of fatigue on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported frequency and severity of nosebleed on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Correlation between patient reported severity of adverse event(s) on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Changes in fat free mass, measured at baseline and the beginning of each cycle, between cycles of cytostatic treatment, and correlation with dose of cytostatic agent (mg) pr. fat free mass (kg)

Correlation between change i absolute and relative leucocyte count from baseline, and total dose of cytostatic agent (mg) pr. fat free mass (kg)

Correlation between change i absolute and relative thrombocyte count from baseline, and total dose of cytostatic agent (mg) pr. fat free mass (kg)

Correlation between change i absolute and relative mmol of haemoglobin/L from baseline, and total dose of cytostatic agent (mg) pr. fat free mass (kg)

Correlation between incidence of absolute neutrophilic granulocyte count \<1.0 - 0.5 x 10e9/L and total dose of cytostatic agent (mg) pr. fat free mass (kg)

Correlation between incidence of absolute neutrophilic granulocyte count \<1.0 x 10e9/L, with a single temperature of \>38.3 degrees C or a temperature of \>= 38 degrees C lasting for more than one hour, and total dose of cytostatic agent (mg) pr. fat free mass (kg)

Correlation between incidence of haemoglobin \<4,9 mmol/L(; transfusion indicated) and total dose of cytostatic agent (mg) pr. fat free mass (kg)

Correlation between incidence of absolute thrombocyte count \<50.0 - 25.0 x 10e9 /L and total dose of cytostatic agent (mg) pr. fat free mass (kg)

Correlation between DLT and total dose of cytostatic agent (mg) pr. fat free mass (kg).

DLT is defined as toxicity leading to one or more of the following: Dose reduction of one or more cytostatic agent(s) (recorded as mg and %). Postponement of cytostatic therapy (recorded as number of days). Discontinuation of cytostatic therapy before scheduled.

Causes of DLT (that are registered in patients records) are classified in one or more of the following categories: Infection, organ impact, myelosuppression, gastrointestinal discomfort, neuropathy or other toxicity (which one is recorded).

Hospitalization note in patient record. Correlation between incidence and number of days of hospitalization and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Zealand University Hospital

University of Copenhagen

Associate Professor

Symptoms and General Pathology

Weight Loss

Head and Neck Neoplasms

Body Weight

Body Weight Changes

12 weeks progressive resistance training (PRT) during and after concomitant chemoradiotherapy. Also optional/voluntary physical activity performed on their own is registered, as well as diet diary.

Control arm. Optional/voluntary physical activity performed on their own is registered, as well as diet diary.

12 weeks supervised resistance training program. Details of the program: 12 weeks, 3 sessions per week, 7 exercises in training machines (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions). In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand)

Progressive Resistance Training

Weekly diary of performed physical activity using the Physical Activity Score (PAS) during the 12-weeks intervention

physical activity

Weekly diet diary during the 12-weeks intervention

Diet diary

Julie Gehl

72 patients with head and neck cancer, undergoing primary treatment with radiation therapy and concomitant weekly cisplatin, will be recruited to this multicentre trial.

Randomized 1:1 to either 12-week progressive resistance training (PRT) program or control arm, starting together with concomitant chemoradiotherapy (CCRT) Stratified by centre, gender, p16-status and body mass index (BMI) below or above 30.

Primary endpoint is difference in change in lean body mass (LBM) between the groups and the endpoint is reduction of LBM loss in intervention arm by 25% compared to control.

Secondary endpoints include side-effects to treatment, change in body composition, physical function and strength, and compliance to PRT. Questionnaires on QoL, diet, voluntary exercise and work affiliation will also be registered.

Blood samples for explorative analyses will be drawn and optional muscle biopsies drawn for proteomics analyses and histological analyses.

The PRT program will start about the onset of radiotherapy. The program consists of 7 exercises in training machines and involves the major muscle groups of the body.

The program has previously been found to successfully restore the loss of lean body mass (LBM) in head and neck cancer patients post-treatment. A group based approach will be used to facilitate a social and motivating training environment for the patients. A pilot study (NCT02068950) showed feasibility of PRT during CCRT.

In addition to baseline data (height, tumor stage, performance status, etc), the following parameters will be registered: Weight, patient reported side effects, as well as a questionnaire on amount of physical activity and food intake.

Physical function and strength will be tested at baseline, after the course of chemoradiotherapy and at the end of the 12-week PRT programme, and at 6 and 12 months follow-up. DXA scans for body composition will be performed using a Lunar iDXA (GE Healthcare).

Blood samples will be drawn at regular intervals during the 12 weeks and at follow-up.

Patient reported quality of life (EORTC Quality of Life Questionnaire (QLQ)-C30 and QLQ-H\&N35) will also be registered.

Muscle biopsies will be taken three times: at baseline, after treatment and after 12-weeks PRT.

Study duration is expected to be 18 months and an additional 12 months for follow-up.

Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy

Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy - The DAHANCA 31 Study

measured by PAS (physical activity scale)

No. of days from end of radiotherapy until back at work at full time (or the hours of work per week as before therapy)

Percent of patients having relapse within 12 months after radiotherapy

Measurement of different cytokines, changes over time and after bout of PRT. Will be measured regularly during the 12 weeks of PRT.

protein will be measured using the proteomic approach. Muscle fiber type and size will be evaluated.

Study specific questionnaire regarding pros and cons of attending the study

Measuring NK-cells. NK-cells may increase after exercise and show tumor inhibiting effect.

Aarhus University Hospital

Odense University Hospital

Danish Head and Neck Cancer Group

Herlev Hospital

M.D., Dr. Med. Sci.

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Carcinoma, Non-Small-Cell Lung

Sarcopenia

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Standard dosing arm based on body surface area

Experimental dosing arm based on individual lean body mass

Cisplatin dosing calculated at the rate of 75 mg/m2

Standard dosing method arm: Cisplatin (chemotherapy) dosing based on body surface area

Cisplatin dosing calculated at the rate of 3.10 mg/kg lean body mass

Experimental dosing method arm: Cisplatin (chemotherapy) dosing based on individual lean body mass

Michael B Sawyer, MD

Vickie Baracos, PhD

Cancer patients are highly variable in their body composition, specifically in the proportion of fat and muscle. Some patients tend to gain fat and lose muscle (or lean body mass) at the same time. These patients can develop severe muscle wasting, termed sarcopenia. Patients with sarcopenia have more severe treatment related toxicity requiring delays, dose reductions and stopping of treatment, and have reduced survival. One potential explanation for this is that patients with sarcopenia have a reduced volume of lean body mass into which chemotherapy drugs are distributed, resulting in a higher concentration and greater toxicity. This study will randomize lung cancer patients to either the standard dosing strategy based on body surface area or experimental, personalized dosing based on lean body mass. Based on retrospective findings in this patient population, the investigators expect to find that severe toxicity will be reduced for sarcopenic patients on the personalized dosing arm based on lean body mass.

Retrospective findings of NSCLC patients treated with a cisplatin based chemotherapy regimen show that although all were given cisplatin at the standard rate of 75 mg/m2 according to lean body mass, when this was expressed in relation to individual lean body mass, there was a high degree of variation. Incidence of dose limiting toxicity was 41% in patients whose dose was within + 25% of the median value. However, sarcopenic patients received on average a 35% higher dose and 80% of these patients experienced severe toxicity requiring dose reduction or termination of therapy, a clinically unacceptable level. The relatively muscular subset of patients with higher lean body mass had a reduced level of severe toxicity compared to those at the median dose. These findings have led to the design of a study with the goal of reducing high levels of toxicity in sarcopenic patients. If the expected level of dose limiting toxicity in sarcopenic patients is 80% based on the standard method of dosing, this could be expected to be reduced to the median value of 41% dose limiting toxicity by the administration of cisplatin scaled to individual lean body mass. Hypothesis: Levels of severe toxicity in sarcopenic patients may be reduced to clinically acceptable levels by cisplatin dosing scaled to 3.1 mg/kg lean body mass compared with standard dosing of 75 mg/m2 based on body surface area.

A Study Comparing Chemotherapy Dosing Based on Either Standard Body Surface Area or Lean Body Mass in Patients With Advanced Lung Cancer

A Phase II Double Blind Randomized Trial Comparing Standard Dosing Based on Body Surface Area Versus Dosing Based on Personalized Lean Body Mass in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Receiving First Line Cisplatin Based Chemotherapy

If a patient has deceased, the date of death is recorded. If a patient is alive, the status is checked again in another 60 days. This is carried out through health records and not through direct contact with the patient.

Canadian Institutes of Health Research (CIHR)

AHS Cancer Control Alberta

All patients are allocated to this arm and will undergod DXA scans and physical testing in addition to usual care/treatment

The patients will undergo 5 DXA scans fro pre- to post treatment

DXA scan

The patients will undergo tests for maximal muscle strength and functional performance before and after treatment

Physical testing

Simon Lønbro, PhD

The goal of this clinical trial is to investigate the changes in body composition in head and neck cancer patients during treatment. The main questions it aims to answer are: What is the rate of lean body mass loss and how is it associated with changes in muscle strength and functional performance? Is the lean body mass loss impacted by adding chemotherapy to the radiation treatment? Participants will be asked to undergo five body composition scans during treatment and undergo tests for muscle strength and functional performance before and after treatment.

The primary aim of the present study is to investigate the rate of decline in body composition (LBM, body weight and fat mass) as well as changes in maximal muscle strength and functional performance during radiation treatment in HNSCC patients and to investigate the association between the loss of LBM and impairments in maximal muscle strength and functional performance. Secondly, the study investigates whether adding cisplatin during chemoradiation induces exacerbated LBM loss compared to radiation alone.

50 patients are expected to be included in the study. Inclusion criteria are: (1) histologically proven squamous cell carcinoma of the larynx, pharynx, or oral cavity, (2) prescribed to radical or post-operative radiotherapy of at least 60 Gy with or without concomitant chemotherapy. Exclusion criteria were palliative radiation or participation in competing research protocols.

Five times during treatment (biweekly), patients will be asked to undergo a Dual Energy X-ray Absorptiometry scan to evaluate changes in lean body mass and fat mass. Before and after treatment patients are asked to perform three test for maximal muscle strength (one repetition maximum knee extension, chest press and leg press) as well as three functional performance test (30 s arm curl, 30 s chair rise and stair climb).

Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation

One repetition maximum in knee extension (unilateral), leg press (unilateral) and chest press (bilateral)

The fastest walking/running time in a stair climb test is recorded (two flights of stairs)

The maximum number of repetitions in 30 s arm curl test are recorded

The maximum number of repetitions in 30 s chair rise test are recorded

Lean body mass in kg determined by DXA scans

Department of Public Health, Denmark

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Carcinoma

Prostatic Neoplasms

Breast Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Inflammatory Agents

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Docetaxel

Female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol

male subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol

Lean Body mass (DEXA scan and Bioelectrical Impedance Assessments) within one week prior to the first docetaxel dose

Lean body mass

Total Body weight (TBW) (scale) within one week prior to the first docetaxel dose

Total body weight

Blood samples will be taken during the first docetaxel administration of the first cycle, just before docetaxel infusion (t=0 min.), 30 min after start of infusion (t=30 min.), just prior to end of infusion (t=55 min.) and between 3 to 6 hours post start infusion following a limited sampling model

bloodsampling

Rien Hoge, PharmD

Frank Jansman, PharmD, PhD

Docetaxel is used as a first line anti-cancer drug in the treatment of several cancers, mainly breast- and metastatic castration-resistant prostate carcinoma.

Anti-cancer drugs are being dosed based on patients estimated Body Surface Area in order to equalize total drug exposure. Nevertheless, docetaxel treatment is characterized by highly interindividual pharmacokinetic variation leading to toxicity and under-treatment.

The investigators will determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlate best to docetaxel exposure (AUC) for both males and females.

Docetaxel is used as a first line anti-cancer drug in the treatment of several cancers, mainly breast- and metastatic castration-resistant prostate carcinoma.

Anti-cancer drugs are being dosed based on patients estimated Body Surface Area in order to equalize total drug exposure. Nevertheless, docetaxel treatment is characterized by highly interindividual pharmacokinetic variation leading to toxicity and under-treatment.

For most anti-cancer drugs, including docetaxel, other anthropometric parameters, such as Lean Body Mass (LBM), have been suggested to be superior to Body Surface Are (BSA) as a determinant for dosing but this has not been implemented in clinical practice.

The investigators will determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlate best to docetaxel exposure (AUC) for both males and females.

The investigators will determine if occurrence of docetaxel toxicity can be related to dose/LBM.

The investigators will determine which methods to measure LBM: DEXA, Bioelectrical Impedance Assessments (BIA) or formula estimates are accurate enough for dosing calculations to be used for dosing docetaxel.

Blood samples for docetaxel concentration measurement (n=4)

Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity

To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC) for both males and females

can docetaxel toxicity be related to dose/LBM? docetaxel toxicity is defined as: number of rates of grade 3/4 toxicity, dose delay, dose reduction, treatment termination and combinations of all four as Dose-Limiting Toxicity (DLT)

To determine which methods to measure LBM: Bioelectrical Impedance As-sessments (BIA) or formula estimates are accurate enough for dosing calculations to be used for dosing docetaxel. These methods will be compared to the LBM derived from the DEXA scan as the general accepted, accurate and validated method for determining LBM.

Radboud University Medical Center

Muscular Atrophy

Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Androgens

All enrolled patient data entered in single group cohort. All patient who started androgen deprivation therapy for prostate cancer can included this cohort by following inclusion and exclusion criteria. We do not planned any intervention on this cohort. We measuring changes of body composition by Inbody 320 in the planned follow-up period.

We planned sub-group analysis for timing of intervention (Intervention 1) , ADT type(Intervention 2), LHRH agonist type(Intervention 3), patients age(Intervention 4), initial PSA level (Intervention 5) and Gleason Grade Group (Intervention 6).

Total Skeletal muscle mass (SMM), Skeletal muscle index (SMI), Relative Skeletal muscle mass index (RASM), Fat body mass (FBM), Body mass index (BMI), Body fat percentage, Body water content, Edema Value were calculated by Inbody 320

Inbody 320

Jungyo Suh, MD.

Chang Wook Jeong, MD. PHD.

This study aimed to evaluate the correlation of change in body composition and oncological outcomes of prostate cancer patients under androgen deprivation therapy(ADT).

Sarcopenia, decrease lean body mass (LBM) is the well-known parameter which negatively related to physical activity, morbidity and patients survival. Aging and decreased blood androgen level are well known risk factors of sarcopenia in male population.

Androgen deprivation therapy (ADT) is commonly performed in advanced or recurred prostate cancer patient and lead to accelerating decreasing blood androgen level. The previous studies defined the sarcopenia after ADT by calculated the (muscle component area) / (total body area) on computed tomography (CT) scan. However, CT scan is not recommended for routine follow up examination of ADT patients thus this measurement of sarcopenia has limitation on clinical usage.

This study using Inbody 320 for measure body composition. Inbody 320 based on multi-frequency Bioelectrical Impedance Analysis(BIA) method that calculated specific body component by differences in impedance indexes of fat, muscle and extracellular body fluid. Inbody measurement show precision accuracy and safety on body composition measurement, thus it frequently used in studies of obesity, nutrition and sports fields.

We calculating the total skeletal muscle mass (SMM), skeletal muscle index(SMI), relative skeletal muscle mass index (RASM), fat body mass (FBM), body mass index (BMI), body fat percentage, body water content, and edema value by Inbody 320 in the patients who treated by ADT in prostate cancer patients. Enrolled patients check the body composition parameters at the baseline (before ADT) and after ADT 3,6,12,18,24 months.

We prospectively measuring the 2 years changes of body composition and sarcopenia after ADT treatment. Patients characteristics (Age, underlying disease), Prostate cancer status (PSA level, Gleason grade group, initial treatment), ADT methods characters (timing, type) and oncological outcome (Recurrence, Metastasis, Castration resistance) were measuring in the cohort population.

Post hoc analysis were performed in the timing (initial, salvage or adjuvant) or type (LHRH agonist, Antiandrogen or surgical castration) of ADT for development of sarcopenia. Sub-arm analysis were performed for assessing that effect of presence of sarcopenia on oncological outcome and functional outcomes after ADT.

Changes in Body Composition With Patients Under Androgen Deprivation Therapy

Body Compositions Change in Patients With Prostate Cancer Treated With Androgen Deprivation Therapy

Lean body mas (kg) / body weight (kg) x 100 (%)

Sum of skeletal muscle mass in limbs (kg) / {height (m)\^2}

fat body mass (FBM) calculated by Inbody 320

HanAll BioPharma Co., Ltd.

Seoul National University Hospital

Nutritional and Metabolic Diseases

Malnutrition

Nutrition Disorders

Gastrointestinal Agents

Pancrelipase

Pancreatin

Maria Elisabeth Lendorf, MD, PhD

The aim of this study is to investigate those nutritional problems contributing to loss of lean body mass in lung and pancreas cancer patients in chemotherapy. Furthermore to investigate alterations in taste and how they correlates with changes in following factors: nutritional intake, physical activity, appetite, food preferences, side effects, fatique and meal perception.

This study will include a recruitment of 50 lung and pancreas cancer patients currently in chemotherapy. They will be observed during a period of 9-12 week, including at least 2 chemotherapy treatments. The presence and severity of the nutritional problems will be examined by observing as many different factors as possible. This includes taste alterations, weight changes, nutritional intake, physical activity, interviews and weekly questionnaires. In relation to this our primary outcome is to investigate the correlation between changes in taste and changes in nutritional intake. Secondarily the investigators want to investigate nutritional intake, physical activity, appetite, food preferences, side effects, fatique and meal perception.

Nutritional Problems in Pallative Cancer

Observational Study of Nutritional Problems in Lung and Pancreas Cancer Patients in Chemotherapy

Changes in taste measured by a sensory test combined with questionnaires, and changes in nutrional intake is measured by photografies of meals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Relationship Between Fat Free Mass and Toxicity of Cytostatics in Cancer Patients	NCT04528745	Pancreas Cancer Colorectal Canc...	Bio Impedance S...	18 Years -	University of Copenhagen
Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy	NCT02557529	Head and Neck N... Weight Loss	Progressive Res... physical activi... Diet diary	18 Years -	Herlev Hospital
A Study Comparing Chemotherapy Dosing Based on Either Standard Body Surface Area or Lean Body Mass in Patients With Advanced Lung Cancer	NCT01624051	Lung Cancer	Standard dosing... Experimental do...	18 Years -	AHS Cancer Control Alberta
Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation	NCT05890859	Head and Neck C... Lean Body Mass Body Compositio...	DXA scan Physical testin...	18 Years -	Department of Public Health, Denmark
Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy	NCT02557529	Head and Neck N... Weight Loss	Progressive Res... physical activi... Diet diary	18 Years -	Herlev Hospital
Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity	NCT01621425	Breast Cancer Metastatic Cast...	Lean body mass Total body weig... bloodsampling	18 Years -	Radboud University Medical Center
Changes in Body Composition With Patients Under Androgen Deprivation Therapy	NCT04037488	Sarcopenia Prostate Cancer	Inbody 320	20 Years -	Seoul National University Hospital
Nutritional Problems in Pallative Cancer	NCT04846985	Lung Cancer Pancreatic Canc...		18 Years -	University of Copenhagen
Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation	NCT05890859	Head and Neck C... Lean Body Mass Body Compositio...	DXA scan Physical testin...	18 Years -	Department of Public Health, Denmark
Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity	NCT01621425	Breast Cancer Metastatic Cast...	Lean body mass Total body weig... bloodsampling	18 Years -	Radboud University Medical Center
Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy	NCT02557529	Head and Neck N... Weight Loss	Progressive Res... physical activi... Diet diary	18 Years -	Herlev Hospital

Spots Global Cancer Trial Database for lean body mass