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Clinical Trials/NCT02192216
NCT02192216
Terminated
Not Applicable

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

Department of Public Health, Denmark1 site in 1 country16 target enrollmentFebruary 2014
ConditionsNeoplasms

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neoplasms
Sponsor
Department of Public Health, Denmark
Enrollment
16
Locations
1
Primary Endpoint
Changes in body composition
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Department of Public Health, Denmark
Responsible Party
Principal Investigator
Principal Investigator

Simon Lønbro

M.Sc., PhD.

Department of Public Health, Denmark

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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).)
  • 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 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 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 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).)

Study Sites (1)

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