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

Not Applicable

Terminated

• Conditions: Neoplasms
• Interventions: Behavioral: Exercise

• Registration Number: NCT02192216
• Lead Sponsor: Department of Public Health, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Primary Completion: 2015-09
• Study Completion: 2016-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Currently receiving curative, adjuvant, neo-adjuvant or palliative chemotherapy
• No documented bone metastases or myelomatosis
• No documented CNS affection
• WHO performance status 0-1
• No chronical thrombocytopenia or leukopenia
• No physical conditions preventing exercise participation
• No serious symptoms of heart disease
• No dementia or mental illness preventing participation
• Signed written concent
• Age above 18 years

Exclusion Criteria

• Participation in systematic resistance training three months prior to inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise & Chemotherapy	Exercise	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.

Primary Outcome Measures

Name	Time	Method
Changes in body composition	Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).	Changes in lean body mass and fat mass wil be assessed using Dual Energy X-Ray Absorptiometry

Secondary Outcome Measures

Name	Time	Method
Changes in underlying biological mechanisms associated with changes in muscle mass	Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).	Analyzed from muscle biopsies from m. vastus lateralis and venous blood samples
Changes in aerobic performance	Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).	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	Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).	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 dynamic muscle strength	Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).	Changes in muscle strength will be assessed using 1 repetition maximum (kg) tests using conventional training equipment.
Changes in functional performance	Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).	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).

Trial Locations

Locations (1)

Dept of Oncology, Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark