Breast Cancer, Cancer-related Fatigue
Conditions
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 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).
Interventions
Supervised progressive resistance training
OTHERSupervised progressive muscle relaxation training (Jacobsen method)
Supervised progressive muscle relaxation training (Jacobsen method)
Sponsors
National Center for Tumor Diseases, Heidelberg
University Hospital Heidelberg
Central Institute of Mental Health, Mannheim
German Cancer Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue measured by Fatigue Assessment Questionnaire (FAQ) | change between baseline and week 13 (end of intervention) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| 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 |
| Cardiorespiratory fitness measured by ergospirometry | change between baseline and week 13 (end of intervention) |
Countries
Germany
Outcome results
None listed