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 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).
Interventions
2x60 minutes per week for 12 weeks
OTHERSupervised progressive muscle relaxation training (Jacobson method)
2x60 minutes per week for 12 weeks
Sponsors
University Hospital Heidelberg
National Center for Tumor Diseases, Heidelberg
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
* 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
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 | Description |
|---|---|---|
| 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) | — |
| Quantity of FoxP3+ CD25+ regulatory T-cells | 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 | — |
| Muscle strength measured at the IsoMed2000® | change between baseline and week 13 (end of intervention) | — |
Countries
Germany
Outcome results
None listed