Progressive Resistance Training Versus Relaxation for Breast Cancer Patients During Chemotherapy: Biological Mechanisms and Effects on Fatigue and Quality of Life

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 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).

Official Title
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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

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 (Jacobsen method)


Participation Criteria
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Eligibility Criteria
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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

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>* Supervised progressive resistance training<br>|
| Active Comparator: Relaxation training<br> | Other: Supervised progressive muscle relaxation training (Jacobsen method)<br>* Supervised progressive muscle relaxation training (Jacobsen method)<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 |
| --- | --- | --- |
| 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) | 
| Biomarker in blood, urine, and saliva |  | change between baseline and week 6 and 13 | 
| Number of patients with adverse events potentially related to the resistance training |  | during the 12-week exercise intervention |