Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy
- Conditions
- Breast CancerCancer-related Fatigue
- Interventions
- Other: Supervised progressive resistance trainingOther: Supervised progressive muscle relaxation training (Jacobson method)
- Registration Number
- NCT01468766
- Lead Sponsor
- German Cancer Research Center
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 160
- 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
- contraindication for exercise
- participation in the BEATE trial or another systematic resistance or relaxation training
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Resistance training Supervised progressive resistance training - Relaxation training Supervised progressive muscle relaxation training (Jacobson method) -
- Primary Outcome Measures
Name Time Method Fatigue measured by Fatigue Assessment Questionnaire (FAQ) change between baseline and week 13 (end of intervention)
- Secondary Outcome Measures
Name Time Method 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) immunmagnetic purification of the Treg (Selection by CD4 und CD25 expression; MACS-beads) by co-culturing of titrated Treg with 3H marked autologuous, polyclonal (anti CD3/CD28) activiated, conventional T-cells (CD4+, CD25+) and subsequent assessment of the proliferation of conventional T-cells.
Zur Bestimmung der Treg-Spezifität wurde eigens eine neue Methode entwickelt, die auf der signifikant erhöhten suppressiven Aktivität antigenspezifisch aktivierter Treg, gegenüber nicht aktivierten Treg, basiert.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
Trial Locations
- Locations (1)
National Center for Tumor Diseases
🇩🇪Heidelberg, Germany