Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy

Study Overview
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Brief Summary
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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).

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

Conditions
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Breast Cancer, Cancer-related Fatigue

Intervention / Treatment
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* Other: Supervised progressive resistance training
* Other: Supervised progressive muscle relaxation training (Jacobson method)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resistance training<br> | Other: Supervised progressive resistance training<br>* 2x60 minutes per week for 12 weeks<br>|
| Active Comparator: Relaxation training<br> | Other: Supervised progressive muscle relaxation training (Jacobson method)<br>* 2x60 minutes per week for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue measured by Fatigue Assessment Questionnaire (FAQ) |  | change between baseline and week 13 (end of intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 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 |