Progressive Resistance Training vs. Relaxation for Breast Cancer Patients During Chemotherapy: A Randomized Controlled Intervention Trial to Evaluate the Biological Mechanisms and Effects of Resistance Training on Fatigue and Quality of Life

German Cancer Research Center1 site in 1 country101 target enrollmentApril 2010

ConditionsBreast Cancer Cancer-related Fatigue

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: German Cancer Research Center
Enrollment: 101
Locations: 1
Primary Endpoint: Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this randomized intervention study is to investigate the effects and biological mechanisms of a supervised 12-week progressive resistance training on fatigue and quality of life in breast cancer patients during chemotherapy. To determine the effect of the exercise itself beyond potential psychosocial effects due to attention by trainers or the group support, patients in the control group have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation training (Jacobsen method).

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

October 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

German Cancer Research Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•breast cancer patient after lumpectomy or mastectomy, stage I-III
•adjuvant chemotherapy
•BMI at least 18

Exclusion Criteria

•contraindication for exercise
•radiotherapy during intervention period

Outcomes

Primary Outcomes

Fatigue measured by Fatigue Assessment Questionnaire (FAQ)

Time Frame: change between baseline and week 13 (end of intervention)

Secondary Outcomes

Number of patients with adverse events potentially related to the resistance training(during the 12-week exercise intervention)
Depression measured by "Allgemeine Depressionsskala" (ADS, the German version of the Center for Epidemiological Studies Depression Scale (CES-D))(change between baseline and week 13 (end of intervention))
Muscle strength measured at the IsoMed2000®(change between baseline and week 13 (end of intervention))
Biomarker in blood, urine, and saliva(change between baseline and week 6 and 13)
Cardiorespiratory fitness measured by ergospirometry(change between baseline and week 13 (end of intervention))
Quality of Life measured by the European Organisation for Research and Treatment of Cancer questionnaire (EORTC-QLQ30/BR23)(change between baseline and week 13 (end of intervention))