Following a control period during active chemotherapy the patients undergo ten weeks of supervised exercise comprised of resistance and aerobic training in combination with protein supplementation during ongoing chemotherapy.

Exercise

Simon Loenbro, M.Sc., PhD

Chemotherapy can induce muscle loss in colorectal, breast and advanced renal cell carcinoma patients. The Danish nation-wide training and rehabilitation offer 'Body \& Cancer' offers intensive resistance and endurance training to all Danish cancer patients receiving chemotherapy with the aim of reducing treatment-related fatigue and physical impairments, but the potential of the training to preserve or improve muscle mass is uninvestigated.

Furthermore, the underlying biological mechanisms of treatment and/or exercise induced changes in muscle mass in cancer patients remains uninvestigated.

Thus, the primary purpose of the present study is to investigate changes in body composition during chemotherapy and after resistance and aerobic training combined with protein supplementation during ongoing chemotherapy in cancer patients. Secondly, we aim to investigate the underlying biological mechanisms of muscle mass regulation in biopsies obtained before and after a control period as well as after 10 weeks of exercise, both during chemotherapy.

We hypothesize that 10 weeks exercise will improve muscle mass and body composition in cancer patients during chemotherapy as compared to a control period during chemotherapy alone.

The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy

Changes in lean body mass and fat mass wil be assessed using Dual Energy X-Ray Absorptiometry

Analyzed from muscle biopsies from m. vastus lateralis and venous blood samples

Changes in muscle strength will be assessed using 1 repetition maximum (kg) tests using conventional training equipment.

Changes in aerobic performance will be assessed using the Watt max bicycle ergometer test. Maximal oxygen consumption (L O2 pr min) will be estimated based on this test.

Changes in cancer related fatigue and quality of life wil be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) questionaire QLQ C30

Changes in functional performance will be assessed using various validated functional performance tests. Thus, changes will be asssessed in 30 s arm curl test (max repetitions) , 30 s chair rise test (max repetitions), stair climbing test (time to ascend to flights of stairs), 10 m maximal gait speed test (time to walk 10 m as fast as possible).

Aarhus University Hospital

Department of Public Health, Denmark

M.Sc., PhD.

Nervous System Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Sarcopenia

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

One-arm study. All included patients will have muscle mass and muscle function evaluated

Included patients have their muscle mass and muscle function evaluated before start on and after completion of oncological treatment.

Evaluation of muscle mass and muscle function

Lise Hoej Omland, MD

Helle Pappot, Professor

This study investigates if reduced muscle mass and muscle function predispose to poor completion of oncological treatment in patients with bladder cancer (including cancer of the renal pelvis, ureter and urethra) and if muscle mass and muscle function change during oncological treatment in these patients. It also evaluates biomarkers for sarcopenia.

The Importance of Muscle Function in Patients With Disseminated Bladder Cancer

We will describe if muscle mass at baseline is correlated to completion of planned systemic oncological treatment

We will describe if muscle strength at baseline is correlated to completion of planned systemic oncological treatment

We will describe if muscle mass change during systemic oncological treatment

Roche Pharma AG

Merck Sharp & Dohme LLC

Beckett Foundation

Onkologisk Forskningsfond

Rigshospitalet, Denmark

Digestive System Diseases

Rare Diseases

Behaviors and Mental Disorders

Esophageal Neoplasms

Esophageal Cancer

Quality of Life

Patients allocated to usual care control will receive the standard patient care program as provided by the department of surgical gastroenterology, Rigshospitalet

Patients allocated to this group will receive usual care plus a supervised aerobic and resistance exercise program at CFAS' facilities consisting of 2 weekly sessions of approximately 60 minutes.

Supervised aerobic and resistance exercise program consisting of 2 weekly sessions of approximately 60 minutes. Patients will perform a test of maximum cardio-respiratory (Watt-max test) and muscle strength (1 repetition maximum \[1-RM\] test) capacity. Using the patient's individual capacity score (Watt-max and 1RM), a personalized exercise program will be prescribed. After a light warm-up, patients will perform 20-30 min of aerobic interval training of stationary bicycle. Resistance training comprises 4 exercises for the major muscle groups: chest press, leg press, lateral pull, and knee extension with 3-4 sets of 8 to 15 repetitions. Each session will be supervised by trained instructors to ensure proper technique, and progression in training load.

Aerobic and Resistance Exercise Training

Jesper F Christensen, PhD

Background:

For patients diagnosed with operable cancer of the gastro-esophageal junction (GEJ), the perioperative course of therapy is associated with severe deconditioning which includes weight loss and poor physical function, which are strong predictor of post-surgical complication and survival . A strong rationale exists to explore how to develop supportive interventions aimed at maintaining/improving muscle function (lean body mass and muscle strength) during the pre-surgical phase.

This study explores the safety, feasibility and efficacy of structured pre- and post-operative exercise training in patient undergoing surgery for cancer of the gastro-esophageal junction.

Subjects: Patients with histologically verified, resectable adenocarcinoma of the GEJ scheduled for treatment af Rigshospitalet, Copenhagen, Denmark.

Methods: In a case-control design, patients will be allocated to either an exercise training intervention group, or a usual-care observational group, based on geographical location. Forty patients will be included in this case-control study and allocated by geographical region as follows; 20 training intervention-cases living in the greater Copenhagen area, and 20 observational control subjects living outside the greater Copenhagen area.

All patients will undergo a total of 5 assessments during the perioperative trajectory; twice prior to surgery (baseline and pre-surgery test), three post-surgery (2 week post- and 15 weeks post-surgery, and at 1-year follow-up).

Assessments include measures of body composition by DXA scan and bioelectrical impedance analysis: systemic inflammation in fasting blood sample; quality of life by self-report questionnaires; physical function by handgrip strength and sit-to-stand test.

As optional procedures, we will collect biological tissue from tumor, muscle and fat biopsies and a 10 ml blood sample at baseline and pre-surgery test only. Also, we will collect blood samples before, during and after an acute exercise bout exercise in order to explore the acute systemic changes in exercise-regulated biomarkers.

BACKGROUND AND RATIONALE Patients diagnosed with operable cancer in upper gastro-intestinal (GI) tract undergo serious therapeutic procedures including invasive surgery combined with chemo- or chemo-radio therapy before (neo-adjuvant) and/or after (adjuvant) surgery. Despite recent advances, especially in surgical techniques and patient care follow-up, the population is faced with one of the worst prognosis for patients with operable staged disease, with a 5-year relative survival of 35-40%. The only possibility of long-term survival is positive surgical outcome, which includes the surgical principle of performing wide clearance, achieving a negative margin (R0 resection), and performing a radical lymphadenectomy. To this end, considerable efforts have been made in recent years optimizing the perioperative period in order to provide the patients and the surgeons with the best possible chances of achieving this surgical outcome.

Adenocarcinoma of the gastro-esophageal junction (GEJ) has increased in incidence over the last quarter century. For patients presenting with localized disease, advances in standards of care have emerged in recent years which have improved disease management. Firstly, comprehensive staging with Computed Tomography (CT), endoscopic ultrasound, diagnostic laparoscopy and fluoro deoxy glucose position emission tomography (18FDG-PET) permits exclusion of patients for curative therapy who might previously have been scheduled for resection. Secondly, evidence supports that esophagectomy is performed in high-volume hospitals by high-volume surgeons. Finally, standard neoadjuvant and adjuvant therapies are performed in most centers for patients with localized esophageal adenocarcinoma which has improved both short- and long-term cancer outcomes.

Prognostic role of Muscle Function in upper GI cancer For all upper GI cancers, including GEJ, the perioperative course of therapy is associated with severe deconditioning which includes weight loss and poor physical function. Over the last decade, strong observational evidence has emerged supporting that poor pre-surgical muscle function, defined as either low muscle mass/area (sarcopenia) or low functional strength, is a strong independent predictor of post-surgical outcomes including mortality, surgical complications and chemotherapy dose-reduction. Importantly, strong evidence across different malignancies has shown that the prognostic value of muscle function is independent from body mass, and may actually be under-reported due to sarcopenic obesity. Thus, current available therapeutic countermeasures in clinical practice, which exclusively involve nutritional interventions, may have limited potential for ameliorating the progressive muscle dysfunction during perioperative treatment for GEJ cancer.

Exercise-Oncology and Upper GI cancer Epidemiological evidence across both heterogeneous and homogeneous groups of cancer patients have shown that low physical activity level after diagnosis is associated with poor disease-specific and overall survival. Despite a general emerging interest, limited attention has been dedicated to the exploration of safety, feasibility and efficacy of structured exercise interventions in patients with upper GI cancer. However, data from recent studies suggests an unmet potential of physical exercise in these patients, with particular emphasis on the pre-surgical period.

STUDY OBJECTIVES Primary Objective

• To explore safety and feasibility of structured exercise in the pre- and post-operative phases among patients undergoing treatment for operable GEJ cancer

Secondary objectives:

* To explore the effect of perioperative exercise training on clinical (e.g. clindo-davien score, pneumonia, anastomotic leakage) physiological (e.g. muscle strength, physical function) and psycho-social (e.g. fatigue, emotional well-being, anxiety) endpoints relative to usual care.
* To explore the prognostic role of pathophysiological profile (physical function, pulmonary function, and body-composition) on post-surgical complications

Explorative objectives:

* To explore molecular adaptations of metabolism and physiology in tumor, muscle and fat samples taken before and after neo-adjuvant chemotherapy in the pre-operative phase in (a sub-group of) patients allocated to exercise training or usual care
* To explore the acute response in immune cells, hormones and cytokines in blood samples taken before, during and after a single exercise session
* Collection of blood and tissue samples for storage in bio-bank for future research.

STUDY DESIGN This prospective, regional-based case-controlled feasibility trial will include in a minimum of 40 patients, including 20 training intervention-cases who are residents in greater Copenhagen Area, and 20 usual care controls living outside the greater Copenhagen area.

Recruitment: Patients will be recruited from the department of surgical gastroenterology, Rigshospitalet, following multidisciplinary medical conference. The responsible physicians will provide oral information and present patients with the written information of the study.

Patients who are willing to participate will sign informed consent, before any study related procedures are performed. After signing informed consent, patients are scheduled for baseline assessment and will be allocated based on geographical location (home-town municipality), to one of two experimental arms:

I) Patient residing OUTSIDE the Copenhagen area, will be allocated to a usual care observation group, which includes nurse-based follow up procedures and information on life style factors (diet, smoking cessation, alcohol, and physical activity).

II) Patients residing WITHIN the Copenhagen area, will be allocated to usual care plus hospital-based aerobic and resistance training at Centre for Physical Activity Research, Rigshospitalet

Procedures will involve assessment-measures conducted a total of 5 times during the study period: twice prior to surgery (baseline and pre-surgery test), twice post-surgery (3 week post- and 15 weeks post-surgery) and at 1-year follow-up.

The following assessments will be performed:

1. Body composition by Bioelectrical Impedance
2. Fasting blood sample for analyses of plasma biochemistry (cholesterol, triglycerides, inflammatory markers, HbA1C)
3. Health related Quality of Life questionnaires
4. Physical function: Handgrip strength and sit-to-stand test.
5. Forced Expiration Volume in 1 second (FEV1)
6. Biological tissue sampling (OPTIONAL): tumor, muscle and fat biopsies and blood samples - only baseline and pre-surgery.
7. Acute Exercise Response (OPTIONAL); blood samples taken before and after a single exercise session.

ANALYTIC PLAN As a feasibility study, this trial is explorative in nature and performed primarily in order to determine whether it is appropriate to advance with a larger scaled randomized controlled trial.

Primary aim

Safety and feasibility of perioperative exercise training in patients with operable GEJ cancer

In order to evaluate the safety and feasibility of the pre- and post-surgical exercise in patients with operable cancer of the gastro-esophageal junction, incidence of serious adverse events in both groups will be determined, and adherence to exercise, assessed by number of training sessions completed in the training group.

Secondary aims

Efficacy of perioperative exercise training to improve clinical, physiological and psycho-social outcomes in patients operable GEJ cancer.

In order to determine whether exercise training has the capacity to improve study outcomes intragroup changes, and inter-group differences for study outcomes will be calculated. For this purpose a random effect analysis will be performed with repeated measures and study outcomes as dependent variables, with the covariates "group", "time" and their interaction as fixed effects, and a random effect of "patient", adjusted for baseline-score, chemotherapy regimen, and surgical procedure (conventional vs laparoscopic).

Prognostic role of pathophysiological profile in patients with operable GEJ cancer

In order to explore the prognostic role of the study assessment outcomes on key clinical endpoints: post-surgical complications, hospital stay duration and disease free and overall mortality risk over the first years after surgery, by a general linear regression models with clinical endpoints being the dependent variable, and study assessment outcomes as the independent variables adjusted for baseline-score, chemotherapy regimen, and surgical procedure (conventional vs laparoscopic). For each variable (physical function, pulmonary function, and body-composition), the predictive value of: I) the diagnostic level (prior to neo-adjuvant therapy), II) the pre-surgical level (after neo-adjuvant treatment) and III) the change score from diagnostic to pre-surgical level (during neo-adjuvant therapy) will be determined.

Dropouts and Missing Observations Patients who wish to drop-out of the study during the intervention-periods will be offered to remain in the study with regard to test-assessments. Patients who drop out prior to 'visit 2' will be replaced. For between-group analyses, all drop-outs and missing observations will be handled by the "missing at random" principle.

ETHICAL CONSIDERATIONS This study will be conducted in accordance with the regional ethical committee and the Declaration of Helsinki (1964) with its subsequent revisions. The protocol and any substantial amendments, the study patient information and consent form, as well as other relevant or requested material have been approved by the local ethics committee (Videnskabsetisk Komite) for the Capital Region of Denmark (Protocol number: H-15014904) and is reported to the Danish Data Protection Agency (Datatilsynet: RH-2016-33, I-Suite nr.: 04396) through Rigshospitalet/Capital Region of Denmark (j.nr. 2012-58-0004).

The project is expected to cause limited risks, side effects and discomfort. All procedures will be performed by experienced physicians, therapists and physiologists with relevant safety, and patients will not experience any kind of delays or complications related to treatment or control process due to participation in the project. Patients may at any time, and without justification, retract their consent.

PeRioperative Study of Exercise Training in Patients With Operable Cancer of the Gastroesophageal Junction

PeRioperative Study of Exercise Training - a None-randomized Feasibility Study: Usual Care Observation vs Exercise Training Intervention in Patients With Operable Cancer of the Gastroesophageal Junction

For the pre-surgical period (at baseline- and during surgery), we will ask for patients' separate consent to do a gastroscopy with sampling of a tumor biopsy; a muscle biopsy from m. vastus lateralis, fat biopsy from subcutaneous abdominal adipose tissue; and a blood sample, all of which will be collected during full anesthesia. A gastroscopy will be performed and endoluminal tumor biopsies will be collected under full anesthesia in patients who have given informed consent, after the diagnostic laparoscopy is completed. Muscle biopsies of approx. 200 mg per biopsy, will be collected from m. vastus lateralis using the Bergstrom-technique, and fat biopsies of approx. 200 mg per biopsy will be collected from the subcutaneous adipose tissue in the abdomen. Standard procedure requires the resection specimen to be dissected and cut open to determine lymph node classification and resection margins.

Recording of adverse events will be separated into two procedures: recordings during trial visits and recordings during exercise sessions.

AE/SAE recording during trial assessment visits This procedure will concern any AE/SAE which can be attributed to study-related assessment procedures during the trial visits, i.e. discomfort during physical tests or blood sampling, which will be recorded immediately during the visit and recorded for the given visit. Also, for each trial visit we will collect patients' self-report of AE/SAEs, which may have occurred during the period since the last trial visit without our knowledge.

AE/SAE recording during exercise sessions For every exercise session, a trained instructor will supervise the exercise program including recording of AE/SAEs during these session

Proportion of exercise sessions completed.

Body fat percentage is assessed measuring bioelectrical impedance in the body using a state-of-the-art Bioelectrical Impedance Analyzer (Tanita MC-780 MA, Tokyo, Japan). The degree of difficulty with which electricity passes through a substance is known as the electrical resistance, and the percentage of fat and other body constituents can be inferred from measurements of this resistance. The analyzer measures body composition using a constant current source with a high frequency current (50kHz, 90µA) with 8 electrodes positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. The current flows into the upper limbs or lower limbs, depending on the body part(s) to be measured. Patients with pacemakers or other electrical implants will not undergo this measure due to safety specifications.

Lean mass is assessed measuring bioelectrical impedance in the body using a state-of-the-art Bioelectrical Impedance Analyzer (Tanita MC-780 MA, Tokyo, Japan). The degree of difficulty with which electricity passes through a substance is known as the electrical resistance, and the percentage of fat and other body constituents can be inferred from measurements of this resistance. The analyzer measures body composition using a constant current source with a high frequency current (50kHz, 90µA) with 8 electrodes positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. The current flows into the upper limbs or lower limbs, depending on the body part(s) to be measured. Patients with pacemakers or other electrical implants will not undergo this measure due to safety specifications.

Body fat mass is assessed measuring bioelectrical impedance in the body using a state-of-the-art Bioelectrical Impedance Analyzer (Tanita MC-780 MA, Tokyo, Japan). The degree of difficulty with which electricity passes through a substance is known as the electrical resistance, and the percentage of fat and other body constituents can be inferred from measurements of this resistance. The analyzer measures body composition using a constant current source with a high frequency current (50kHz, 90µA) with 8 electrodes positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. The current flows into the upper limbs or lower limbs, depending on the body part(s) to be measured. Patients with pacemakers or other electrical implants will not undergo this measure due to safety specifications.

Concentrations of total cholesterol will be measured in fasting blood samples by standard laboratory methods.

Concentrations of LDL-cholesterol will be measured in fasting blood samples by standard laboratory methods.

Concentrations of HDL-cholesterol will be measured in fasting blood samples by standard laboratory methods.

Concentrations of triglyceride will be measured in fasting blood samples by standard laboratory methods.

HbA1C will be measured in fasting blood samples by standard laboratory methods.

Concentrations of TNFa will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

Concentrations of IL-6 will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

Concentrations of IL-8 will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

Concentrations of IL-10 will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

Patient reported quality of life is measured by Functional Assessment of Cancer Treatment (FACT)

Patient reported sleep quality is measured by the Pittsburgh Sleep Quality Index (PSQI) questionaire

Patient reported Anxiety and Depression is measured by the Hospital Anxiety and Depression Scale (HADS).

Patient reported physical activity is measured by the Internations Physical Activity Questionaire (IPAQ) - short form

Sit-to-stand test: Lower-body physical function is assessed by 30-second sit-to-stand test. Using a chair fixed to the ground with a seat 45 cm above the ground subjects will be instructed to sit in the middle of the chair, back straight, arms crossed over their chest, feet flat on the floor. Correct technique will be demonstrated first, and subjects will practice for two-three repetitions. On the signal "go" subjects will be asked to stand then return to the seated position, as many times as possible in 30 seconds.

Handgrip strength is assessed by hand-held dynamometer. Grip strength is measured in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score.

FEV1 is evaluated by validated assessment measure of pulmonary function. The patient is instructed to make a complete inspiration and then inserts the mouthpiece into the mouth, closes the lips around it but with the jaws apart, and blows out through the mouth as hard and as completely as possible with strong verbal encouragement given throughout this sequence. The FEV1 score is the fraction of the total volume which is expired in the first second

Jesper Frank Christensen, PhD

Nutritional and Metabolic Diseases

Colorectal Neoplasms

Carcinoma

Carcinoma, Hepatocellular

Cholangiocarcinoma

Malnutrition

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Bile Duct Cancer

Other Dietary Supplements

All Drugs and Chemicals

Omega 3 Fatty Acid

oral nutritional supplement rich in eicosapentanoic acid

Matthias Pirlich, MD

Malnutrition is a frequent symptom of various malignant diseases and is frequently observed in patients with gastrointestinal tumors. Eicosapentanoic acid (EPA) has been introduced as specific and anticatabolic acting substrate in cancer patients. Only few randomized trials are available which investigated the effect of EPA in form of an EPA-enriched, protein- and energy-dense oral nutritional supplement mostly in patients with pancreatic carcinoma.

Therefore, the effect of an EPA-rich oral nutritional supplement for two months on functional state and quality of life in patients with other gastroenterological tumors and weight loss is investigated in this randomized prospective trial.

Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors

Pilot Study: Randomized Controlled Trial on the Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors

Pfrimmer Nutricia GmbH, Erlangen , Germany

Charite University, Berlin, Germany

Dr. Matthias Pirlich

Blood and Lymph Conditions

Immune System Diseases

Frailty

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Exercise Only

* 3 sessions per week
* Aerobic + Resistance Exercises

Exercise + Nutritional Guidance

* 3 sessions per week
* Aerobic + Resistance Exercises
* Dietary assessment at baseline and during with guidance on eating a healthy diet provided

Control group will receive no exercise or nutritional guidance

EXE+ Nutritional Guidance

David Bartlett, PhD

Ellie Miles

This randomised control clinical trial aims to investigate the effects of exercise training and diet on physical and functional fitness and immunological and metabolic changes in adults with chronic lymphocytic leukaemia. Investigators will randomise participants to either 12 weeks of supervised/semi-supervised exercise only, exercise + nutritional guidance, or no exercise.

This study aims to perform a randomised control trial of exercise or exercise plus nutritional guidance on the physiological and immunological health of adults diagnosed with chronic lymphocytic leukaemia (CLL). Recruited participants will be randomised to either 12 weeks of an exercise-only program, an exercise-plus nutritional guidance program or a no-exercise control group. Fasting blood samples collected at Baseline and 12 weeks will measure absolute CLL cell counts, immune function, and inflammatory and metabolic biomarkers. A series of physical fitness assessments will be assessed at baseline and 12 weeks to determine physiologic reserve and resilience against external stressors. Additionally, participants will be asked to return 12 weeks after completing the intervention to assess the legacy effects of the intervention on the same physiological and blood-based biomarkers of health.

Recruited participants will be randomised to either exercise only, exercise + nutritional guidance, or control for 12 weeks

Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia

Reassessment of CRF following 12 weeks of unguided exercise training

Reassessment of absolute number of CD19+/CD5+ CLL cells following 12 weeks of unguided exercise training

A blood sample will be taken and assessed for CD19+/CD5+ CLL frequency using flow cytometry and total lymphocyte counts to determine the absolute number of CLL cells in x10\^9/L

Cardiopulmonary exercise testing will be conducted to assess changes in fitness

Frailty will be determined by a series of validated physical function tests that provide a score of 0-1(Robust), 2 (Pre-Frail), 3-5 (Frail)

Estimated one repetition maximum and repetitions to failure using machine-based weights

Ultrasound and near-infrared spectroscopy assessment of muscle fuel usage

Quality of life will be determined by the EORCT-QLQ-C30 questionnaire

Measurement of muscle oxygenation via near infrared spectroscopy during a single session of acute exercise

Measurement of in vitro B-CLL cell proliferation by flow cytometry

Measurement of in vitro immune cell fuel utilisation by high resolution respirometry and mass spectrometry

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy	NCT02192216	Neoplasms	Exercise	18 Years -	Department of Public Health, Denmark
The Importance of Muscle Function in Patients With Disseminated Bladder Cancer	NCT04144270	Urinary Bladder...	Evaluation of m...	18 Years -	Rigshospitalet, Denmark
PeRioperative Study of Exercise Training in Patients With Operable Cancer of the Gastroesophageal Junction	NCT02722785	Gastro-esophage...	Aerobic and Res...	18 Years - 80 Years	Rigshospitalet, Denmark
Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors	NCT00168987	Colorectal Neop... Hepatocellular ... Cholangiocarcin...	oral nutritiona...	18 Years -	Charite University, Berlin, Germany
Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors	NCT00168987	Colorectal Neop... Hepatocellular ... Cholangiocarcin...	oral nutritiona...	18 Years -	Charite University, Berlin, Germany
The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy	NCT02192216	Neoplasms	Exercise	18 Years -	Department of Public Health, Denmark
The Importance of Muscle Function in Patients With Disseminated Bladder Cancer	NCT04144270	Urinary Bladder...	Evaluation of m...	18 Years -	Rigshospitalet, Denmark
Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia	NCT06379282	Chronic Lymphoc... Frailty Muscle Function Immune Function Lipid Cell; Tum...	HIT EXE+ Nutritiona...	18 Years -	University of Surrey

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