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

February 28, 2018 updated by: Simon Lønbro, Department of Public Health, Denmark

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Dept of Oncology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise & Chemotherapy
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.
Behavioral: Exercise
Other Names:
  • Aerobic exercise
  • Resistance training
  • Protein supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body composition
Time Frame: 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
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in underlying biological mechanisms associated with changes in muscle mass
Time Frame: 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
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 dynamic muscle strength
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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
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
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Department of Public Health, Denmark

Collaborators

Aarhus University Hospital

Investigators

  • Principal Investigator: Simon Loenbro, M.Sc., PhD, Dept. of Public Health, Sect. for Sports Science, Aarhus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SKDM2014
  • 41408 (Other Identifier: Denmark: Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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