Neoplasms

Blood and Lymph Conditions

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Cardiotoxicity

Neoplasms by Histologic Type

Hematologic Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

All Drugs and Chemicals

Carbamide Peroxide

N,N-dimethylarginine

Enzyme Inhibitors

The study group will include patients with acute myeloid leukemia receiving chemotherapy, aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before the start of polychemotherapy, in whom in the course of chemotherapy treatment after the next course of treatment a decrease in global longitudinal strain of 15% or more relative to the initial values will be revealed.

The control group will consist of patients with acute myeloid leukemia receiving chemotherapy, aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before the start of polychemotherapy, in whom no signs of myocardial disease will be detected during chemotherapy. and endothelial dysfunction.

Careful history taking, including using questionnaires, to identify risk factors for the development of cardiovascular diseases using the SCORE scale.

History taking

Anthropometry: measurement of body weight and height. Calculation of body surface area using the Du Bois formula.

Anthropometry

Before and after each course of chemotherapy: Complete blood count with counting the number of erythrocytes, leukocytes, leukocyte formula, platelets, erythrocyte sedimentation rate.

Complete blood count

Before and after each course of chemotherapy: Biochemical blood test with the determination of the amount of total protein, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, creatinine, urea, AlAT, AsAT, LDH, glucose, C-reactive protein, troponin T, proBNP.

Biochemical blood test

Before and after each course of chemotherapy: Coagulogram parameters (fibrinogen, APTT, INR).

Coagulogram

Before the start of the treatment and after each course of chemotherapy: Immunoenzymatic analysis of the level of endothelin-1, asymmetric dimethylarginine.

Immunoenzymatic analysis of the level of endothelin-1, asymmetric dimethylarginine

Before the start of the treatment and after each course of chemotherapy: Stress echocardiography with the definition of global longitudinal deformation of the myocardium.

Stress echocardiography with the definition of global longitudinal deformation of the myocardium

Before the start of the treatment and after each course of chemotherapy: Triplex scanning of neck vessels.

Triplex scanning of neck vessels

Before and after each course of chemotherapy: Electrocardiography.

Electrocardiography

Before the start of the treatment and after each course of chemotherapy: Ultrasound of the abdominal cavity (with calculation of the area of the spleen) and lymph nodes.

Ultrasound of the abdominal cavity (with calculation of the area of the spleen) and lymph nodes

Before the start of the treatment: Cytogenetic examination of the bone marrow to determine genetic abnormalities.

Cytogenetic examination of the bone marrow to determine genetic abnormalities.

Before the start of the treatment and after each course of chemotherapy: Cytological examination of bone marrow cells with cytochemical examination.

Cytological examination of bone marrow cells with cytochemical examination

Before the start of the treatment: Immunophenotypic examination of the bone marrow by flow cytometry.

Immunophenotypic examination of the bone marrow by flow cytometry

Before the start of the treatment: Determination of the presence of a FLT3 mutation using the PCR Method.

Determination of the presence of a FLT3 mutation using the PCR Method

Before the start of the treatment and after each course of chemotherapy: Examination of microcirculation by laser Doppler flowmetry using the LAKK-OP apparatus (NPP Lazma, Moscow, 2011) with respiratory and occlusion tests.

laser Doppler flowmetry

Igor Davydkin, Doctor of Medical Sciences

Angelika Antipova

Igor Davydkin

Acute myeloid leukemia (AML) is a clonal neoplastic disease of the hematopoietic tissue associated with a mutation in the precursor cell of hematopoiesis, which results in a differentiation block and uncontrolled proliferation of immature myeloid cells.

Anthracycline antibiotics have been an integral part of the treatment of acute myeloid leukemia since the 1970s. However, the clinical usefulness of anthracyclines is limited primarily by the high incidence of cardiotoxicity. According to the European Society of Cardiology guidelines for cardio-oncology, cardiovascular toxicity is defined as any impairment of cardiac function associated with anticancer treatment, as the term encompasses both a wide range of possible clinical manifestations and an etiological relationship with various treatments, including chemotherapy, radiation therapy, immunotherapy and treatment with targeted drugs. Cardiovascular toxicity can be acute, subacute or delayed, manifesting many years after chemotherapy or radiation therapy, involving a number of cardiac structures, which can lead to the development of heart failure, coronary heart disease, valvular heart disease, arrhythmias, including cardiac conduction disorders and diseases of the pericardium.

Anthracycline-induced cardiotoxicity is the negative effect of anthracyclines on normal cardiac activity due to their toxic effects on the heart muscle and the cardiac conduction system. Anthracycline-induced cardiotoxicity manifests as asymptomatic left ventricular dysfunction in 57% of treated patients and restrictive or dilated cardiomyopathy leading to congestive heart failure (CHF) in 16% to 20% of patients. Anthracycline-induced congestive heart failure is often resistant to therapy and has a mortality rate of up to 79%. Thus, there is a need for early detection of cardiovascular dysfunction associated with chemotherapy treatment of acute myeloid leukemia in order to timely prescribe drug therapy.

Purpose of the study To optimize the early detection of endothelial dysfunction and left ventricular myocardial contractility in patients with acute myeloid leukemia during chemotherapy treatment based on a comprehensive assessment of instrumental and laboratory research parameters.

Expected results Based on a comprehensive analysis using laser Doppler flowmetry, stress echocardiography with the determination of global longitudinal strain of the myocardium, biochemical markers of endothelial damage and cardiac biomarkers, a correlation between violations of the contractility of the left ventricular myocardium and violations of the vasoregulatory function of the vascular endothelium will be revealed, which will allow developing an algorithm for early detection of cardiomyopathy and vascular complications in patients with acute myeloid leukemia during chemotherapy treatment.

Acute myeloid leukemia (AML) is a clonal neoplastic disease of the hematopoietic tissue associated with a mutation in the precursor cell of hematopoiesis, which results in a differentiation block and uncontrolled proliferation of immature myeloid cells.

It is believed that AML affects an average of 3-5 people per 100,000 people per year. At the same time, the incidence increases sharply at the age of over 60 years and amounts to 12-13 cases per 100 thousand of the population in people over the age of 80 years. The median age of this disease is 65 years. With a population of 140 million inhabitants in Russia, the estimated incidence rate (according to European and American researchers) should be about 5 thousand cases.

Anthracycline antibiotics have been an integral part of the treatment of acute myeloid leukemia since the 1970s. Anthracycline is usually given for 3 days (eg, daunorubicin 45-90 mg/m 2 daily, idarubicin 12 mg/m 2 daily) in combination with cytarabine (100-200 mg/m 2 daily) continuously for 7 days ) ("7+3" mode). Anthracyclines block the synthesis of DNA and RNA by inhibiting the enzyme topoisomerase IIβ and mitochondrial topoisomerase I. The subsequent disruption of DNA replication and transcription prevents the proliferation of rapidly dividing cells. In addition, anthracyclines damage DNA, proteins, and cell membranes by creating free oxygen radicals.

The clinical usefulness of anthracyclines is limited primarily by the high incidence of cardiotoxicity. According to the European Society of Cardiology guidelines for cardio- oncology, cardiovascular toxicity is defined as any impairment of cardiac function associated with anticancer treatment, as the term encompasses both a wide range of possible clinical manifestations and an etiological relationship with various treatments, including chemotherapy, radiation therapy, immunotherapy and treatment with targeted drugs. Cardiovascular toxicity can be acute, subacute or delayed, manifesting many years after chemotherapy or radiation therapy, involving a number of cardiac structures, which can lead to the development of heart failure, coronary heart disease, valvular heart disease, arrhythmias, including cardiac conduction disorders, and diseases of the pericardium.

Anthracycline-induced cardiotoxicity is the negative effect of anthracyclines on normal cardiac activity due to their toxic effects on the heart muscle and the cardiac conduction system. It is believed to be mediated in part by reactive oxygen species generated by anthracycline treatment, which leads to lipid peroxidation and DNA damage in cardiomyocytes. Other putative causes of anthracycline-induced cardiotoxicity include accumulation of cardiotoxic anthracycline metabolites in the heart, disruption of calcium homeostasis, mitochondrial damage, and induction of apoptosis.

Anthracycline-induced cardiotoxicity manifests as asymptomatic left ventricular dysfunction in 57% of treated patients and restrictive or dilated cardiomyopathy leading to congestive heart failure (CHF) in 16% to 20% of patients. Anthracycline-induced congestive heart failure is often resistant to therapy and has a mortality rate of up to 79%. Thus, there is a need for early detection of cardiovascular dysfunction associated with chemotherapy treatment of acute myeloid leukemia in order to timely prescribe drug therapy.

Purpose of the study To optimize the early detection of endothelial dysfunction and left ventricular myocardial contractility in patients with acute myeloid leukemia during chemotherapy treatment based on a comprehensive assessment of instrumental and laboratory research parameters.

Research objectives

1. To assess the state of endothelial function in patients with acute myeloid leukemia receiving chemotherapy based on a comprehensive assessment, including laser Doppler flowmetry and biochemical markers of endothelial damage (endothelin-1, asymmetric dimethylarginine).
2. To characterize the contractility of the left ventricular myocardium in patients with acute myeloid leukemia during chemotherapeutic treatment based on the indicators of stress echocardiography with the determination of global longitudinal deformation of the myocardium, as well as to assess the presence of myocardial damage by determining the level of highly sensitive troponin and brain natriuretic peptide.
3. To study the relationship between dynamic indicators of microcirculation, determined by laser Doppler flowmetry, with indicators of contractility of the left ventricular myocardium, detected using stress echocardiography with the determination of global longitudinal deformation of the myocardium, and the results of laboratory methods for assessing the function of the endothelium and myocardium.
4. To determine the frequency of development of various phenotypes of cardiovascular toxicity.
5. To identify the most significant prognostic criteria for the development of cardiotoxicity in patients with acute myeloid leukemia receiving chemotherapy.

Scientific novelty

1. For the first time, an algorithm for early detection of endothelial dysfunction and left ventricular myocardial contractility in patients with acute myeloid leukemia during chemotherapy treatment will be developed.
2. For the first time, the vasoregulatory function of the endothelium and the contractility of the left ventricular myocardium in patients with acute myeloid leukemia receiving chemotherapy will be studied based on a comprehensive assessment using laser Doppler flowmetry, stress echocardiography with the determination of global longitudinal deformation of the myocardium, biochemical markers of endothelial damage and cardiac biomarkers.

Practical significance It is planned to develop an algorithm for early detection of endothelial dysfunction and left ventricular myocardial contractility in patients with acute myeloid leukemia during chemotherapy treatment based on a comprehensive assessment using laser Doppler flowmetry, stress echocardiography with the determination of global longitudinal myocardial strain, biochemical markers of endothelial damage and cardiac biomarkers. .

Expected results Based on a comprehensive analysis using laser Doppler flowmetry, stress echocardiography with the determination of global longitudinal strain of the myocardium, biochemical markers of endothelial damage and cardiac biomarkers, a correlation between violations of the contractility of the left ventricular myocardium and violations of the vasoregulatory function of the vascular endothelium will be revealed, which will allow developing an algorithm for early detection of cardiomyopathy and vascular complications in patients with acute myeloid leukemia during chemotherapy treatment.

Research hypothesis:

The proposed algorithm for the early detection of cardiovascular complications in patients with acute myeloid leukemia receiving chemotherapy treatment is an effective method for diagnosing cardiovascular complications at subclinical stages for the timely initiation of their therapy.

Study Design In total, it is planned to study 100 patients with acute myeloid leukemia receiving chemotherapy, aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before the start of polychemotherapy.

The study group will include patients with acute myeloid leukemia receiving chemotherapy, aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before the start of polychemotherapy, in whom in the course of chemotherapy treatment after the next course of treatment a decrease in global longitudinal strain of 15% or more relative to the initial values will be revealed.

The control group will consist of patients with acute myeloid leukemia receiving chemotherapy, aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before the start of polychemotherapy, in whom no signs of myocardial disease and endothelial dysfunction will be detected during chemotherapy.

Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With AML

Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With Acute Myeloid Leukemia

Change of global longitudinal strain of the myocardium according to stress echocardiography by 15% or more relative to the values obtained before the start of chemotherapy treatment.

Change of the microcirculation index according to the results of laser Doppler flowmetry in relation to the values obtained before the start of chemotherapy treatment.

Change of the coefficient of variation of microcirculation according to the results of laser Doppler flowmetry in relation to the values obtained before the start of chemotherapy treatment.

Change of the level of highly sensitive T-troponin, which goes beyond the reference values, in relation to the values obtained before the start of chemotherapy treatment.

Change of the level of brain natriuretic peptide that goes beyond the reference values, in relation to the values obtained before the start of chemotherapy treatment.

Change of the level of asymmetric dimethylarginine that goes beyond the reference values, in relation to the values obtained before the start of chemotherapy treatment.

Change of the level of endothelin-1, which goes beyond the reference values, in relation to the values obtained before the start of chemotherapy treatment.

Samara State Medical University

Mathilde Touvier, Dr

Pilar Galan, Dr

Serge Hercberg, Pr

Emmanuelle Kesse-Guyot, Dr

Sandrine Péneau, Dr

Léopold Fezeu, Dr

Chantal Julia, Dr

Valentina Andreeva, Dr

Allès Benjamin, Dr

Baudry Julia, Dr

Deschasaux Mélanie, Dr

The NutriNet-Santé study was set up to investigate nutrition and health relationships. Specifically, it was the first web-based cohort worldwide on such a large scale (n=171 000 as of 2021) focused on the complex link between nutrition and health status. It is characterized by a very detailed assessment of nutritional exposure and dietary behavior.

https://etude-nutrinet-sante.fr/ https://info.etude-nutrinet-sante.fr/en

NutriNet-Santé is a large-scale (n=171,000) web-based cohort coordinated by EREN, launched in France in 2009 to investigate nutrition and health relationships. All required ethics authorisations have been obtained (listed here). NutriNet-Santé participants regularly fill questionnaires through a dedicated and secure website, providing extensive, high-quality nutritional and non-nutritional data, including repeated data on socio-demographics and lifestyle (yearly), anthropometrics (every 6 months), dietary intake (every 6 months), physical activity (IPAQ questionnaire, yearly)5 and health status (every 6 months). NutriNet-Santé is characterised by a very detailed and up-to-date assessment of nutritional exposure and dietary behaviours. Usual dietary intakes are assessed at baseline and every 6 months thereafter through a series of 3 non-consecutive randomly assigned 24h dietary records. Daily energy, alcohol, micro- and macronutrient intakes are calculated using the published NutriNet-Santé food composition database (\>3,500 generic items). All major health events (e.g., cancers, cardio- and cerebrovascular diseases) are reported by the participants and validated by an expert committee of physicians based on medical records, and/or retrieved from the French National Health Insurance medico-administrative databases to limit potential reporting bias. In turn, mortality data are obtained from the exhaustive French National Mortality Registry (CépiDC). The number of incident events already registered is as follows: 4,200 cancers and 1,240 deaths. A sub-sample of the cohort (n=20,000) provided blood and urine samples, currently stored at -80°C in EREN's biobank.

Samples of serum, plasma, and buffy-coats (for genetic analyses), as well as urine samples was set up for 19 600 subjects of the cohort.

The NutriNet-Santé Study

The NutriNet-Santé Study. A Web-based Prospective Cohort Study of the Relationship Between Nutrition and Health and of Dietary Patterns and Nutritional Status Predictors

self reported though validated scales and/or questionnaires

combination of previsously listed mental and physical health outcomes

Institut National de la Santé Et de la Recherche Médicale, France

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Conservatoire national des Arts et Métiers

University of Paris 13

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Nutritional and Metabolic Diseases

Skin and Connective Tissue Diseases

Syndrome

Necrosis

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Wasting Syndrome

Cachexia

Lipodystrophy

HIV Wasting Syndrome

Blood-Borne Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

Virus Diseases

RNA Virus Infections

Genital Diseases

Urogenital Diseases

Immunologic Deficiency Syndromes

Skin Diseases

Skin Diseases, Metabolic

Metabolic Diseases

Lipid Metabolism Disorders

Weight Loss

Body Weight

Body Weight Changes

Thinness

Nutrition Disorders

Anti-Retroviral Agents

Anti-HIV Agents

Caroline Chantry

Joseph Cervia

The purpose of this study is to see how beginning or changing anti-HIV medications affects the body composition (weight, height, growth, body fat, and muscle mass, or fat and muscle distribution) of HIV-infected children. This study also looks at how changes in body composition relate to changes in viral load (level of HIV in the blood), CD4 cell counts, height, and weight in HIV-infected children. This study also compares changes in body composition to levels of cytokines (proteins in the body that affect some immune cells) in HIV-infected children who are beginning or changing anti-HIV therapy.

Though studies have been done on adults, little is known about the effects of HIV infection and anti-HIV drugs on body composition in children. One theory is that changes in body composition can predict the failure of anti-HIV treatment. If this is true, body composition measurements can be as useful as CD4+ cell counts in determining drug effectiveness.

Despite accumulating data in adults, little information is available regarding the effects of HIV infection and antiretroviral therapy on body composition in children. Preliminary information indicates that lean body mass is lost in preference to fat mass in HIV-infected children, supporting the theory that failure to thrive in HIV infection is often cytokine mediated. It can be hypothesized that changes in body composition (lean body mass) may predict changes in weight growth velocity and may give an early clinical indication of treatment failure. If so, body composition measurement may yield an additional outcome measure for clinical trials, equivalent in utility to other laboratory measures of treatment response, e.g., persistent CD4+ cell count changes. Additionally, if body composition changes are highly correlated with responses in viral load, body composition may prove to be a more affordable measure of antiretroviral effectiveness in developing countries.

This study is a nonrandomized, observational study. Children are recruited to each of 4 age strata:

Stratum A: 1 month to 18 months. Stratum B: greater than 18 months to 3 years. Stratum C: greater than 3 years to 8 years. Stratum D: greater than 8 years to less than 13 years. Children beginning or changing antiretroviral therapy and fulfilling the study specifications may be enrolled in the study. Children have 5 outpatient clinic visits, at entry and at 12, 24, 36, and 48 weeks, for anthropometry, body composition by bioelectrical impedance analysis, cytokine levels, viral load, CD4+ cell count, and markers of lipid and glucose metabolism.

The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children

Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Allergy and Infectious Diseases (NIAID)

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Cola

Kerry Courneya, PhD

Recent studies have shown that survival after a colorectal cancer diagnosis may be affected by a person's activity level and body size. This research says that for colorectal cancer patients, the less active and more obese they are, the more likely they are to have a cancer recurrence or die from their cancer. Chemotherapy has been shown to reduce activity levels, fitness, and body size in some cancer patients. However, it is not known how chemotherapy specific for colon cancer patients affects their activity levels, fitness, and body size. The main goal of our study will be to look at how chemotherapy treatments affect the fitness, activity levels, and body size in colon cancer patients. In order to do this, we will measure these variables before chemotherapy treatments, and at 1 and 6 months following the end of treatment. Our results will show how chemotherapy affects fitness, activity levels, and body size in colon cancer patients and provide data to help in designing an exercise intervention specifically for colon cancer survivors.

Background Information: Recent evidence has suggested that the physical activity levels and body composition of colorectal cancer survivors can impact the disease-free and overall survival following diagnosis, with those individuals who are more overweight or obese and less active at greater risk of a recurrence of or dying from colorectal cancer (Meyerhardt et al, 2006a,b; Digman et al, 2006). Chemotherapy treatments have been shown to improve survival in a number of cancer populations, but unfortunately they have also been shown to negatively impact numerous physiological and psychological variables, including reduced exercise capacity, self-reported physical functioning and activity levels, and negative changes in body composition (Schmitz et al, 2005). This suggests that chemotherapy treatments may negatively impact variables that have been associated with survival in individuals diagnosed with colorectal cancer. However, this research has been conducted in cancer populations other than colorectal cancer patients, hence the specific impact of the chemotherapy treatments for colorectal cancer on these outcomes is not known.

Objectives: The primary objective of the study is to determine the effects of chemotherapy treatments on the aerobic capacity and body composition of colon cancer patients. Secondary objectives are to determine the effects of chemotherapy treatments on quality of life, fatigue, performance status, self-reported and objectively measured physical functioning, exercise behaviour, oxygen uptake kinetics, muscular strength, and anthropometric variables.

Study Design: The study parameters assessed will include descriptive information on demographic, lifestyle and medical variables; a graded exercise test with metabolic measurement to determine peak oxygen consumption (VO2peak); air-displacement plethysmography (BOD POD) testing and anthropometric measurements (waist \& hip circumferences, waist-to-hip ratio, body mass index) to assess body composition; a questionnaire to determine cancer-specific quality of life and fatigue (Functional Assessment of Cancer Treatment - Colorectal and Fatigue); performance status assessment (Eastern Cooperative Oncology Group performance status); self-reported (Medical Outcomes Study Short Form-36 Physical Function Scale) and objectively measured (Physical Functional Performance-10 and Senior's Fitness Tests) physical functioning; self-reported exercise behavior (Godin Leisure Time Exercise Questionnaire); submaximal exercise test with metabolic measurement to determine oxygen uptake kinetics; an 8-repetition maximum test to assess upper (bench press) and lower (leg press) body muscular strength; and a fasted blood sample to be used for future biomarkers assays. All of these assessments will be completed at baseline prior to the subject's first chemotherapy infusion, and 1 and 6 months after the completion of all chemotherapy infusions.

The following calculation was used to estimate the required sample size based on the primary outcome of aerobic capacity (Peak Oxygen Consumption; VO2peak): n = 2 + C (s/d)2 (Snedecor et al, 1989), where C is a constant equal to 7.85 for a power of 0.80 and alpha of 0.05, s is the standard deviation of 6.0 ml/kg/min, and d is a 3.5 ml/kg/min difference between groups. Therefore, a sample size of 25 subjects is required to detect a 1 Metabolic Equivalent (MET) or 3.5 ml/kg/min reduction in VO2peak in colorectal cancer survivors following the completion of chemotherapy treatment, with a standard deviation (SD) in oxygen consumption of 6.0 ml/kg/min, a power of 0.80, and an alpha set at p\<0.05 (two-tailed). Each 1 MET change in exercise capacity has been positively associated with a 12% difference in overall survival in the general population (Myers et al, 2002). A sample of 30 subjects will be recruited to account for any subjects lost to follow-up. To compare the effects of chemotherapy treatment on the study assessments to colon cancer surgery alone, 10 subjects will be recruited to complete all of the study assessments at the same 3 time points to allow for a "surgery only" comparison group.

Inclusion/Exclusion Criteria: Inclusion criteria will include: 1)histologically confirmed colon cancer (Stage III and those Stage II patients deemed high-risk 2) approval of the treating oncologist 3) they will receive chemotherapy 4) able to understand and provide written informed consent in English 5) 18+ years of age 6) no uncontrolled co-morbidities (including hypertension, cardiac illness, psychiatric condition, etc.) negative ECG as assessed during maximal graded exercise test \*Ten patients meeting all eligibility requirements except for criteria 3 will be recruited to the study to serve as "surgery only" controls.

Exclusion criteria include 1) metastatic or recurrent colon cancer patients; 2) pregnancy; 3) any uncontrolled medical condition that would be a contraindication to exercise (assessed by treating oncologist); 4) unwilling to attend, travel to, or participate in the assessments at all 3 time points.

Recruitment: Patients will be recruited from outpatient colorectal clinics at the Cross Cancer Institute. The project coordinator will be present at all clinics, and in conjunction with the treating oncologist and clinic nurses will screen patient lists to determine eligibility for that day. The treating medical oncologist will have final determination of patient eligibility for the study and will introduce the trial to the patient if they are deemed to meet all eligibility requirements. If the patient expresses interest, he or she will be approached by the project coordinator who will discuss the study in further detail and will also give the patient a study information package. The patient will be told that a follow-up phone call will be made in the next few days to confirm if the patient is interested in participating in the trial. If the patient is still interested, all baseline testing appointments will be scheduled. Based on an estimate of 8 new colon cancer patients eligible for the study in clinic per week and a 15% accrual rate, it should take approximately 36 weeks to recruit the required number of subjects (n = 30).

Statistical Analysis: Data will be analyzed using SPSS version 15.0 software (SPSS, Inc., Evanston, IL). The principal analyses of end points will employ the last observation carried forward approach. Independent t-tests will be used to test for variables differentiating between patients accepting/declining participation and completing/dropping out of study. Descriptive statistics will be used to summarize all study assessment data at each time point. The changes in measured outcomes from baseline to post-chemotherapy (4 weeks post) to recovery (24 weeks post-chemotherapy) will be analysed using a one-way analysis of variance for repeated measures. Any differences in study outcomes between subjects receiving chemotherapy versus those who are receiving surgery alone will be analysed using a two-way analysis of variance for repeated measures.

Stopping Rules: Subjects are free to withdraw from the study at any time, which includes stopping at any point during any of the study assessments.

Data Safety Monitoring Committee: Ethical and scientific approval will be obtained from Alberta Cancer Board and the Health Ethics Research Board at the University of Alberta. All data will be number coded so that the identity of participants cannot be traced. All data will be kept in a secure, locked cabinet in the Behavioral Medicine Laboratory and will only be accessible to members of the research team. The local Institutional Research Ethics Boards will oversee the validity and integrity of data by conducting periodic audits of study records.

The safety of participants will be of primary concern at all times. Study investigators will monitor participants during all study assessments. All adverse events, however minor, will be recorded. All serious adverse events will be reported to the local Institutional Research Ethics Boards, as well as each participant's treating oncologist. The project coordinator, under the supervision of the principal investigator, will be responsible for reporting any serious adverse events.

References:

Dignam JJ, Polite BN, Yothers G, Raich P, Colangelo L, O'Connell MJ, Wolmark N. (2006). Body mass index and outcomes in patients who receive adjuvant chemotherapy for colon cancer. Journal of the National Cancer Institute. 98:1647-1654.

Meyerhardt JA, Giovannucci EL, Holmes MD, Chan AT, Chan JA, Colditz GA, Fuchs CS. (2006a). Physical activity and survival after colorectal cancer diagnosis. Journal of Clinical Oncology. 24:3527-3534.

Meyerhardt JA, Heseltine D, Niedzwiecki D, Hollis D, Saltz LB, Mayer RJ, Thomas J, Nelson H, Whitton R, Hantel A, Schilsky RL, Fuchs CS. (2006b). Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: findings from CALGB 89803. Journal of Clinical Oncology. 24:3535-3541.

Schmitz KH, Holtzman J, Courneya KS, Masse LC, Duval S, Kane R. (2005). Controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. Cancer Epidemiology, Biomarkers \& Prevention. 14:1588-1595.

Snedecor G, Cochran W, Cox D. (1989). Statistical Methods (8th ed). The Iowa State University Press.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With AML	NCT05703126	Acute Myeloid L... Cardiotoxicity Endothelial Dys...	History taking Anthropometry Complete blood ... Biochemical blo... Coagulogram Immunoenzymatic... Stress echocard... Triplex scannin... Electrocardiogr... Ultrasound of t... Cytogenetic exa... Cytological exa... Immunophenotypi... Determination o... laser Doppler f...	18 Years - 65 Years	Samara State Medical University
The NutriNet-Santé Study	NCT03335644	Diet, Food, and... Exercise Diseases Catego... Cohort Studies Adult Anthropometry Humans Internet Surveys and Que... Mortality		15 Years -	University of Paris 13
The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children	NCT00006064	HIV Infections HIV Wasting Syn... Lipodystrophy		1 Month - 12 Years	National Institute of Allergy and Infectious Diseases (NIAID)
The NutriNet-Santé Study	NCT03335644	Diet, Food, and... Exercise Diseases Catego... Cohort Studies Adult Anthropometry Humans Internet Surveys and Que... Mortality		15 Years -	University of Paris 13
Aerobic Capacity and Body Composition in Colon Cancer Patients	NCT00470782	Colonic Neoplas...		18 Years -	AHS Cancer Control Alberta

Spots Global Cancer Trial Database for anthropometry