Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy - A Randomised Controlled Intervention Trial

German Cancer Research Center1 site in 1 country160 target enrollmentFebruary 2011

ConditionsBreast Cancer Cancer-related Fatigue

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: German Cancer Research Center
Enrollment: 160
Locations: 1
Primary Endpoint: Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
Status: Completed
Last Updated: 10 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 immunological and inflammatory biomarkers in breast cancer patients during adjuvant radiotherapy. 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

February 2011

End Date

July 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

German Cancer Research Center

Responsible Party

Principal Investigator

Karen Steindorf

Prof. Dr. Karen Steindorf / Dr. Karin Potthoff, National Center for Tumor Diseases, Heidelberg

German Cancer Research Center

Eligibility Criteria

Inclusion Criteria

•histologically confirmed primary breast cancer, stage I-III, after lumpectomy or mastectomy, indication for adjuvant radiotherapy
•BMI: 18-40
•ability to understand and follow the study protocol

Exclusion Criteria

•contraindication for exercise
•participation in the BEATE trial or another systematic resistance or relaxation training

Outcomes

Primary Outcomes

Fatigue measured by Fatigue Assessment Questionnaire (FAQ)

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

Secondary Outcomes

Quantity of FoxP3+ CD25+ regulatory T-cells(change between baseline and week 13 (end of intervention))
Inflammatory parameter CRP, SAA and IL-6(change between baseline and week 13 (end of intervention))
Circulating lymphocytes subpopulations (CD4+, CD8+, CD56+)(change between baseline and week 13 (end of intervention))
Specificity of FoxP3+ CD25+ regulatory T-cells (in a subgroup only)(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))
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))
Cardiorespiratory fitness measured by ergospirometry(change between baseline and week 13 (end of intervention))
Number of participants with lymphedema, pain, nausea, dyspnea, or tachycardia as a measure of safety of resistance training during radiotherapy.(events with onset or worsening during the 12-week intervention period are considered)
Cognitive performance measured by the Trail-Making-Test(change between baseline and week 13 (end of intervention))
Toxicity of radiotherapy (acute radio dermatitis; LENT-SOMA classification for late effects)(acute toxicity during radio therapy and late effects 6 weeks after end of radio therapy are recorded)