Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy - A Randomised Controlled Intervention Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Resistance training
Intervention: Supervised progressive resistance training (Other)
Relaxation training
Intervention: Supervised progressive muscle relaxation training (Jacobson method) (Other)
Outcomes
Primary Outcomes
Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
Time Frame: change between baseline and week 13 (end of intervention)
Secondary Outcomes
- 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))
- 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))
- 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)
Investigators
Karen Steindorf
Prof. Dr. Karen Steindorf / Dr. Karin Potthoff, National Center for Tumor Diseases, Heidelberg
German Cancer Research Center