Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Liver Neoplasms

Neoplastic Processes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Participants allocated to CON receive the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark.

Participants allocated to CON are allowed to exercise on their own initiative or participate in any standard care hospital- or municipality-based exercise training program.

Participants allocated to EX receive the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark, and postoperative exercise training.

The postoperative exercise training program consists of 8 weeks of supervised and home-based exercise 5 times/week. The intensity and duration are progressively increased during the postoperative period

Exercise training

Jesper F Christensen, PhD

Surgery is a primary treatment modality in the intended curative treatment of colorectal liver metastases (CRLM). However, surgery elicits a cascade of potentially detrimental stress responses that may drive the onset of long-term disease progression. Exercise training is emerging as an adjunct treatment in surgical oncology and holds potential to modify the surgical stress response. Against this background, we designed the present randomized controlled trial to evaluate the therapeutic role of pre- and postoperative exercise training in patients with CRLM undergoing open liver resection.

BACKGROUND:

Colorectal cancer is the third most frequent type of cancer in Denmark, with more than 5000 new cases annually. Colorectal liver metastases (CRLM) develop in nearly one fourth of all patients with colorectal cancer, and poses a poor prognostic outlook, with low survival rates and short time to disease progression. Surgical resection, either upfront or following downstaging with perioperative treatments, confers substantial survival benefit in patients with CRLM, and may even comprise a curative treatment modality. However, surgery elicits a cascade of biological responses characterized by increased dissemination of tumor cells and modulation of neuroendocrine, inflammatory, and immunological factors. These local and systemic perturbations typically persist for days to weeks following surgery and may independently or in concert drive the onset of long-term disease progression. Under normal physiological conditions, exercise training is a potent modulator of immune function, systemic inflammation, and the neuroendocrine system, raising the possibility that perioperative exercise training may ameliorate the surgical stress response during and after surgery. However, in a recent systematic review and meta-analysis (submitted), we found that the effects and safety of preoperative and early postoperative exercise are unknown in patients with gastrointestinal cancers (including CRLM) due to lack of studies, widespread methodological issues, and poor ascertainment and reporting of adverse events. Safety is arguably the single most important consideration for the application perioperative exercise, and methodological robust trials evaluating the safety and tolerability of perioperative exercise training along with preliminary information on treatment efficacy are needed to inform the application of exercise in surgical oncology.

Against this background, we designed the present randomized controlled trial to evaluate the therapeutic role of postoperative exercise training in patients with CRLM undergoing open liver resection. The primary trial objective and hypothesis are:

1. To compare the number of serious adverse events (SAE) in standard care plus postoperative exercise (EX) vs. standard care alone (CON) in patients with colorectal liver metastases scheduled to undergo open liver resection. The primary research hypothesis is that the number of SAEs is non-inferior in EX vs. CON

   The key secondary study objectives and hypotheses are:
2. To compare the effect of EX vs. CON on incidence of postoperative hospital admissions in patients with CRLM undergoing surgery. We hypothesize that the incidence of postoperative hospital admissions are non-inferior in EX vs. CON
3. To compare the effect of EX vs. CON on relative dose intensity of adjuvant chemotherapy and time from surgery to initiation of adjuvant chemotherapy in patients with CRLM undergoing surgery. We hypothesize that the relative dose intensity of adjuvant chemotherapy and time from surgery to initiation of adjuvant chemotherapy are non-inferior in EX vs. CON.
4. To compare the effect of EX vs. CON on selected patient-reported symptomatic adverse events in patients with CRLM undergoing surgery
5. To compare the effect of EX vs. CON on surgical stress responses (neuroendocrine, inflammatory, and immune factors) in patients with CRLM undergoing surgery.

   The secondary study objectives are:
6. To evaluate the feasibility of EX.
7. To compare the effect of EX vs. CON on functional capacity, muscle strength, aerobic capacity, and body composition in patients with CRLM undergoing surgery.
8. To compare the effect of EX vs. CON on clinical outcomes in patients with CRLM undergoing surgery.
9. To compare the effect of EX vs. CON on patient-reported outcomes in patients with CRLM undergoing surgery.
10. To compare the effect of EX vs. CON on circulating tumor DNA and DNA methylation in patients with CRLM undergoing surgery
11. To evaluate the effects of acute pre- and postoperative exercise on neuroendocrine, immunological, and inflammatory factors in patients with CRLM undergoing surgery.
12. To conduct explorative preclinical sub-studies.

TRIAL DESIGN:

This trial is a single-center, randomized, controlled, parallel-group trial performed at Centre for physical Activity (CFAS), Rigshospitalet, Copenhagen, Denmark, and Department of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.

A total of 60 participants with CRLM will be included and randomly allocated 2:1 to standard care and postoperative exercise training (EX) or standard care alone (CON). The participants will undergo two trial visits at CFAS during the study period: One preoperative trial visit (1-3 days after inclusion and 2-7 days before surgery) and one post-surgery trial visit (8 weeks after discharge). For each visit, the participants will be assessed for body composition and anthropometrics, resting cardiovascular factors, standard blood biochemistry, aerobic capacity (VO2peak, ventilatory threshold), maximal muscle strength, and functional performance. In addition, blood samples will be taken before, during, and immediately after surgery, and on post-operative day 1, 3, and 15 and neuroendocrine, inflammatory, and immune factor will be analyzed. Patient-reported outcomes will be collected at all trial visits and 1, 2, and 3 years after randomization. Data from medical records regarding mortality and disease recurrence will be collected up to 3 years after randomization. As an optional procedure, we will collect blood samples before, during, and after a pre- and a postoperative supervised exercise training session.

The participants and the exercise intervention instructors cannot be blinded, given the nature of the intervention. The outcome assessors of the primary and key secondary outcomes (adverse events and markers of surgical stress, respectively) will be blinded. For practical reasons, the outcome assessors of the following secondary outcomes will be not be blinded: resting cardiovascular factors, aerobic capacity, muscle strength, functional performance, and body composition and anthropometrics.

Postoperative Exercise Training in Patients With Colorectal Liver Metastases Undergoing Surgery (ELMA)

Proportion of patients who have not died from colorectal cancer 3 years after randomization

Proportion of patients who are alive 3 years after randomization

Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100

RDI (%) of exercise, defined as prescribed exercise dose / performed exercise dose x 100

Incidence of early termination of attended exercise sessions, defined as termination of an exercise session before the prescribed exercises have been performed

Incidence of exercise intervention disruptions, defined as a period of ≥ 7 days without an attended exercise session

Incidence of exercise sessions requiring dose modifications, defined as any deviation from the prescribed exercise

Incidence of permanent discontinuations of the exercise intervention, defined as participants that withdraw entirely from the exercise intervention, regardless of whether they remain in the trial

Time from discharge to first attended postoperative exercise session

Changes in patient-reported symptomatic adverse events (paint, dizziness, nausea, fatigue, other)

Changes in resting systolic blood pressure

Changes in resting diastolic blood pressure

Changes in peak oxygen consumption assessed during an incremental exercise test (ergometer bicycling) to volitional exhaustion

Changes in ventilatory threshold assessed during an incremental exercise test (ergometer bicycling) to volitional exhaustion

Changes in peak power output assessed during an incremental exercise test (ergometer bicycling) to volitional exhaustion

Changes in leg press one repetition maximum (1RM)

Changes in hand grip strength, assessed using a dynamometer

Changes in total lean mass, assessed by dual energy x-ray absorptiometry (DXA)

Changes in appendicular lean mass, assessed by DXA

Changes in abdominal fat mass, assessed by DXA

Changes in total fat mass, assessed by DXA

Changes in fat percentage, assessed by DXA

Changes in total cholesterol concentration

Changes in low-density lipoprotein cholesterol concentration

Changes in high-density lipoprotein cholesterol concentration

Change in glycated hemoglobin A1c concentration

Changes in patient-reported physical well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C)

Changes in patient-reported social well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C)

Changes in patient-reported emotional well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C).

Changes in patient-reported functional well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C).

Changes in patient-reported colorectal-cancer specific health-related quality of life assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C).

Changes in patient-reported general health-related qualify of life assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C).

Changes in patient-reported trial outcome index assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C).

Changes in patient-reported in health-related quality of life (total score) assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C).

Changes in patient-reported depression, assessed using the Hospital Anxiety and Depression Scale (HADS).

Changes in patient-reported anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS).

Changes in patient-reported weekly duration of walking, assessed using the International Physical Activity Questionnaire (IPAQ)

Changes in patient-reported weekly duration of moderate intensity PA, assessed using the International Physical Activity Questionnaire (IPAQ)

Changes in patient-reported weekly duration of vigorous intensity PA, assessed using the International Physical Activity Questionnaire (IPAQ)

Changes in patient-reported weekly duration of total PA, assessed using the International Physical Activity Questionnaire (IPAQ)

Changes in patient-reported weekly sitting time, assessed using the International Physical Activity Questionnaire (IPAQ)

Changes in blood IL-1β concentration during acute perioperative exercise

Changes in blood IL-6 concentration during acute perioperative exercise

Changes in blood IL-8 concentration during acute perioperative exercise

Changes in blood IL-10 concentration during acute perioperative exercise

Changes in blood interferon- γ concentration during acute perioperative exercise

Changes in blood C-reactive protein concentration during acute perioperative exercise

Changes in blood leukocyte cell counts (total and per type \[eosinophils, basophils, lymphocytes, monocytes, neutrophils\]) during acute perioperative exercise

Changes in blood natural killer cell count during acute perioperative exercise

Changes in blood T cell count during acute perioperative exercise

Changes in blood ACTH concentration during acute perioperative exercise

Changes in blood cortisol concentration during acute perioperative exercise

Changes in blood adrenaline concentration during acute perioperative exercise

Changes in blood noradrenaline concentration during acute perioperative exercise

Changes in concentation of IL-6 in LPS-stumulated whole blood

Changes in concentation of TNF-a in LPS-stumulated whole blood

Incidence of postoperative hospital re-admissions, defined as any non-scheduled ≥ 24 h hospitalization

RDI (%) of adjuvant chemotherapy, calculated as the actual dose intensity / standard dose intensity x 100%

Time from surgery to initiation of adjuvant chemotherapy

Patient-reported symptomatic adverse events, assessed using the using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Changes in blood interferon- γ concentration

Changes in blood leukocyte cell counts (total and per type \[eosinophils, basophils, lymphocytes, monocytes, neutrophils\])

Changes in blood adrenaline concentration

Changes in blood noradrenaline concentration

Rigshospitalet, Denmark

Principal investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants will engage in 2-3 supervised high intensity aerobic and resistance exercise sessions per week.

Participants will continue daily routine as usual and given an informational flyer on physical activity and cancer.

Participants will perform high-intensity aerobic and resistance exercise

High Intensity Interval Training

Darpan I Patel, PhD

This study aims to examine the use of high-intensity interval training (HIIT) and resistance training on docetaxel chemotherapy tolerability and toxicity in metastatic prostate cancer.

Exercise has been shown to decrease tumor progression and mitigate treatment-related side effects, such as fatigue, while increasing physical fitness. In this study, investigators will test the effects of a high intensity interval training and resistance exercise program on how patients with metastatic prostate cancer tolerate docetaxel chemotherapy. Participants assigned to the exercise intervention will be asked to meet with a personal trainer 2-3 times per week for supervised exercise sessions. All participants will be asked to complete electronic questionnaires during their chemotherapy sessions that ask about their physical and mental wellbeing.

Outcomes assessments and analysis will be done by study staff blinded to the participant allocation

Adjuvant High-intensity Interval Training During Chemotherapy in Metastatic Prostate Cancer Patients

Pilot Study of a Randomized Chemo-periodized Adjuvant High-Intensity Interval Training Intervention to Improve Chemotherapy Tolerance in Men With Metastatic Prostate Cancer

Compare changes in levels of serum measurements of biomarkers such as tumor necrosis factor alpha (pg/ml) and interleukins (pg/ml).

Compare changes in fat free mass and fat mass measured with dual energy x-ray absorptiometry (DEXA) scan from baseline to end-of-study

Compare changes in participant's 1 repetition maximum (1RM) weight between baseline and end-of-study for chest press, leg press, seated row, leg extension, and grip strength. Participants will lift progressively heavier weight in each exercise until unable to lift any extra weight. This will be recorded as the 1RM weight. Total load will be calculated across exercises, with higher load values indicating higher muscular strength.

Compare participant's time to completion on a 400 meter walk test from baseline to end-of-study. This submaximal test serves as a surrogate measure of aerobic fitness.

Compare cognitive function changes between groups over time measured by Cambridge Neuropsychological Test Automated Battery (CANTAB).

Number of Changes or delays in docetaxel treatment schedule or dosing (tolerability)

Rates of CT CAE v.5 reported symptoms related to treatment

Change in score on a 16 point scale using a 5-point response scale focused on patient-reported neuropathic symptoms and concerns:

0 =Not at all

1. =A little bit
2. =Somewhat
3. =Quite a bit
4. =Very much

Range of scores is from 0-64 with a lower score indicating less neuropathic symptoms and concerns.

Change in FACIT-G score. FACT-G contains four subscales measuring physical well being, social well-being, emotional well-being, and functional well being containing 7,7,6, and 7 items respectively. Responses to questions are scored:

0 =Not at all

1. =A little bit
2. =Somewhat
3. =Quite a bit
4. =Very much

Scores from the 4 scales are added to give a total score between 0-108, where a lower score indicates better physical, social, emotional and functional well-being.

Change in score on this subscale, which contains 13 items assessing the consequences of fatigue. Each item is rated on a 5-point Likert scale ranging from 0=not at all to 4=very much.

Totals range from 0-52 with a lower score indicating less fatigue.

Change in score for 30 questions to assess the quality of life with 9 multi-item scales: 5 functional scales; 3 symptom scales; and a global health and quality-of-life (GHQL) scale. A few 1-item symptom measures are included. Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (GHQL and the Financial Impact scale are not included). Prior to calculating the mean, the symptom scales are reversed to obtain a uniform direction of all scales.

All scales and 1-item measures range from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).

Change in score on this 19-question assessment will be used to assess sleep quality and sleep habits.

The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.

Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

Change in score calculated using the following formula: Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). The first 3 questions relate to type of activity and the 4th to number of times a week the activity is engaged in for at least 15 minutes.

EXAMPLE Strenuous = 3 times/wk Moderate = 6 times/wk Light = 14 times/wk Total leisure activity score = (9 × 3) + (5 × 6) + (3 × 14) = 27 + 30 + 42 = 99

Godin Scale Score: Interpretation 24 units or more: Active 14-23 units: Moderately Active Less than 14 units: Insufficiently Active/Sedentary

The University of Texas Health Science Center at San Antonio

Lee Jones, PhD

Jessica Scott, PhD

The purpose of this study is to develop a secure method of collecting physiologic information from patients with cancer. The researchers will use this information to learn more about how physiologic data may relate to cancer diagnosis and response to treatment, and to identify factors that may lead to higher or lower risk of cancer.

Project 1: HealthKit This prospective registry cohort study will aim to recruit a total of 3,000 patients and 500 adults without a history of cancer. The targeted patient cohorts / settings will aim to be : (1) pre-treatment / during treatment: patients with newly diagnosed early-stage, low-grade, or locally advanced solid tumors that are either pre- or during treatment, (2) post-treatment: patients with primary solid tumor diagnosed from 2015 onwards that are post-treatment, (3) advanced disease setting: patients diagnosed with metastatic or high-grade disease, (4) patients enrolled onto investigational trials in the early drug development (EDD) Service, (5) patients admitted to Urgent Care Center (UCC), and (6) patients completing a Baseline Medical History Questionnaire (BMH) as part of standard intake in an MSK care clinic. This study will accrue patients receiving care at any MSK site. Adults without a history of cancer will be recruited as a comparison group. The targeted adults without a history of cancer cohorts will aim to be (n=250/cohort): (7) adults without a history of cancer \<50 years of age, and (8) adults without a history of cancer aged greater than or equal to 50 years.

Project 2: DigIT-Ex This prospective registry cohort study will aim to recruit a total of 120 patients and 24 adults without a history of cancer. The targeted adult patient cohorts / settings will be (n=12/cohort), excluding cohort 6, which will be (n=48): (1) patients scheduled to undergo bone marrow transplantation, (2) patients newly diagnosed with acute myeloid leukemia (AML), (3) patients scheduled to undergo surgery for localized prostate cancer (4) patients scheduled to undergo surgery for lung cancer, (5) patients scheduled to undergo total neoadjuvant therapy for advanced rectal cancer, (6) patients scheduled to undergo antiandrogen therapy for advanced prostate cancer, and (7) patients scheduled to undergo chemotherapy for metastatic pancreatic cancer. The targeted adults without a history of cancer cohorts will be (n=12/cohort): (8) individuals without a history of cancer aged less than 50 years, and (9) individuals without a history of cancer aged greater than or equal to 50 years.

Remote Digital Physiologic Data Collection in Cancer: An MSK Registry Protocol

Remote Digital Physiological Data Collection in Cancer: An MSK Registry Protocol

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

to create a repository and infrastructure to address novel questions of clinical importance.

University of California, Los Angeles

Memorial Sloan Kettering Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients will be assessed and screened prior the intervention. After the physical assestment they will attend 2 days a week for the supervised, and controlled sessions of physical exercise, performed in the nature (Retiro park in Madrid). To meassure the intensity of the program, they will use the 1-10 Borg ratio of perceived exertion (RPE).

Patients will be asked to mantain an active lifestyle, performing physical activity regularly.

An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested.

Patients will be screened and then divided in diferent groups, depending on both their cardiovascular and physical capacity.

Then they will perform 2 sessions of combined strength and endurance training per week for 16 weeks.

At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life.

Oncological physical exercise intervention

An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested Patients will be suggested to mantain active physical activities in their daily life.

At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life.

Active Physical Activities intervention

Soraya Casla-Barrio, PhD

Helios Pareja-Galeano, PhD

Mónica Castellanos, MSc

Jaime Pérez-Vélez, BSc

The goal of this interventional study is to analyze the impact of a supervised oncological exercise intervention in surviving breast cancer patients. The main questions it aims to answer are:

* Evaluate the efectivity of a supervised individualized and adapted oncological physical exercise program in the cardiovascular fitness of the participants.
* Analyze the impact of this intervention in the body composition, functionality and quality of life of the parcitipants

Participants will perform a controlled and adapted program, supervised by an especialized professional during 16 weeks.

Researchers will compare this intervention group, where the supervised program will take place, with a control group, where the patients will perform regular physical activity (non-supervised) to see the changes in the efectivity and impact in cardiovascular fitness, body composition and quality of life.

Doesn´t exist. Patients were allocated depending their preferences

Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals

The information will be shared with the patients after the completion of every test.

This information will be shared only with the participant researchers of this study.

Evaluate the effectiveness of the program in the improvement of the cardiovascular capacity in breast cancer survivors (looking for a difference of 3,49 ml/kg/min of oxigen consumption), using a submaximal cardiovascular test.

Analyze the effect of the physical exercise program in the body weight, the body mass index (BMI), percentages in body fat, abdominal fat, fat free mass, bone mass and total body water in patinets that surviuve breast cancer via bioimpedancy

Know the impact of the oncologic physical exercise program in the physical functionality of the patients, using the 6 minutes walk test and the 30 seconds sit and stand test.

Meassure the level of adherence to the oncologic physical exercise program, registering the assistence to te sessions

Evaluate the effect of the intervention in the level of exercise performed by the patients, using the IPAQ cuesttionaire (short version)

Evaluate the impact of the physical exercise program in the fatigue levels of the participants via the FACT-F questionnaire

Evaluate the impact of the oncologilcal physical exercise program in the quality of life of the patients in relation with their heath, usint the EQ5D questionnaire.

Evaluate the impact of the physical oncologic program in the anxiety and depression levels of the subjects using the Hospitalary Anxiety and Depression Scale (HADS)

Tigers Running Club

PhD in Exercise Pyshiology

Nervous System Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Esophageal Neoplasms

Sarcopenia

Wasting Syndrome

Cachexia

Esophageal Cancer

Participants allocated to control receive first line chemotherapy the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark.

Participants allocated to control are allowed to exercise on their own initiative or participate in any standard care hospital- or municipality-based exercise training program. There will be no diet restrictions.

Participants allocated to intervention receive first line chemotherapy and the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark.

The intervention consists of resistance training and a daily protein supplement.

10 weeks of resistance training 3 times pr. week.

Resistance training

A daily supplement of protein to ensure a daily intake of 1,6g protein/kg bodyweight

Protein supplement

Rikke Krabek, MD

Rikke Krabek

Casper Simonsen, PhD

Patients with advanced gastroesophageal cancer are in great risk of losing skeletal muscle mass and developing cancer cachexia. Low skeletal muscle mass has a negative impact on quality of life, impairs physical function, increases toxicity from anti-neoplastic treatment, as well as increases risk of death.

Resistance training and protein supplements have the potential to stimulate muscle anabolism and counteract loss of skeletal muscle mass. Therefore, the investigators have designed a randomized controlled feasibility trial to evaluate the feasibility, safety and the therapeutic effect of resistance training and protein supplements in patients with advanced gastroesophageal cancer undergoing first line chemotherapy.

A total of 54 patients with advanced gastroesophageal cancer will be recruited from the Department of Oncology, Copenhagen University Hospital, Rigshospitalet and randomly allocated 2:1 to standard care plus resistance training 3 times pr. week and a daily supplement of protein or to standard care alone.

Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer

Changes in differential counts (total and per type: eosinofils, basofils, neutrofils, monocytes and lymphocytes)

Changes in low-density lipoprotein cholesterol

Changes in high-density lipoprotein cholesterol

Changes in glucose tolerance (2-hpur oral glucose tolerance test)

Muscle glucose uptake during insulin stimulation after acute exercise

Muscle protein synthesis during insulin stimulation after acute exercise.

Modifications of proteins after acute exercise. Muscle biopsies will be subjected to mass spectrometry-based proteomic analysis.

Modifications of mithochondrial regulation. Signaling of mitochondiral fission, fusion and mitophagy will be examined in mucle biopsies.

The number of attended exercise training sessions relative to the number of planed exercise sessions

The actual amount consumed relative to the amount prescribed over the intervention period

SAE will be recorded during trial assessment visits and through medical records. This procedure will concern any SAE during the trial period. For each trial visit we will collect patients' self-report of SAEs, which may have occurred during the period since the last trial visit.

The actual dose relative to the prescribed minimum dose

Termination of an exercise session before the prescribed exercises have been performed

Incidence of permanent withdrawal from the intervention before intervention period has ended.

Changes in bone mineral density, assessed by DXA

Changes in thickness of the vastus lateralis, assessed by ultrasound

Changes in skeletal muscle index, assessed by diagnostic CT scans

Changes in skeletal muscle attenuation, assessed by diagnostic CT scans

Changes in adipose tissue index, assessed by diagnostic CT scans

Proportion of patients who have not died from gastroesophageal cancer 1 and 2 years after randomization

Proportion of patients who have not died 1 and 2 years after randomization

Treatment tolerance assessed by the delivery of chemotherapy (relative dose intensity)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Postoperative Exercise Training in Patients With Colorectal Liver Metastases Undergoing Surgery (ELMA)	NCT04751773	Colorectal Live...	Exercise traini...	18 Years - 100 Years	Rigshospitalet, Denmark
Adjuvant High-intensity Interval Training During Chemotherapy in Metastatic Prostate Cancer Patients	NCT05156372	Prostate Cancer... Castrate Resist... Metastatic Pros... Metastatic Pros...	High Intensity ...	18 Years -	The University of Texas Health Science Center at San Antonio
Remote Digital Physiologic Data Collection in Cancer: An MSK Registry Protocol	NCT05390827	Solid Tumor		18 Years - 90 Years	Memorial Sloan Kettering Cancer Center
Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals	NCT05882578	Breast Cancer Exercise Oncolo... Cancer Survivor... Fitness Capacit...	Oncological phy... Active Physical...	18 Years -	Tigers Running Club
Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer	NCT05650827	Gastro-esophage...	Resistance trai... Protein supplem...	18 Years -	Rigshospitalet, Denmark
Effects of Creatine Supplementation in Breast Cancer Survivors	NCT04207359	Breast Cancer Chemotherapy Ef... Muscle Weakness Muscle Loss Exercise	Creatine	18 Years - 75 Years	The University of Texas Health Science Center at San Antonio
Adjuvant High-intensity Interval Training During Chemotherapy in Metastatic Prostate Cancer Patients	NCT05156372	Prostate Cancer... Castrate Resist... Metastatic Pros... Metastatic Pros...	High Intensity ...	18 Years -	The University of Texas Health Science Center at San Antonio

Spots Global Cancer Trial Database for exercise oncology