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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01468766
Other study ID # BEST
Secondary ID
Status Completed
Phase N/A
First received October 11, 2011
Last updated April 18, 2016
Start date February 2011
Est. completion date July 2014

Study information

Verified date April 2016
Source German Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date July 2014
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Supervised progressive resistance training
2x60 minutes per week for 12 weeks
Supervised progressive muscle relaxation training (Jacobson method)
2x60 minutes per week for 12 weeks

Locations

Country Name City State
Germany National Center for Tumor Diseases Heidelberg

Sponsors (3)

Lead Sponsor Collaborator
German Cancer Research Center National Center for Tumor Diseases, Heidelberg, University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Gollhofer SM, Wiskemann J, Schmidt ME, Klassen O, Ulrich CM, Oelmann J, Hof H, Potthoff K, Steindorf K. Factors influencing participation in a randomized controlled resistance exercise intervention study in breast cancer patients during radiotherapy. BMC — View Citation

Klassen O, Schmidt ME, Scharhag-Rosenberger F, Sorkin M, Ulrich CM, Schneeweiss A, Potthoff K, Steindorf K, Wiskemann J. Cardiorespiratory fitness in breast cancer patients undergoing adjuvant therapy. Acta Oncol. 2014 Oct;53(10):1356-65. doi: 10.3109/028 — View Citation

Potthoff K, Schmidt ME, Wiskemann J, Hof H, Klassen O, Habermann N, Beckhove P, Debus J, Ulrich CM, Steindorf K. Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study. BMC Cancer. 2013 Mar 28;13:162. doi: 10.1186/1471-2407-13-162. — View Citation

Scharhag-Rosenberger F, Kuehl R, Klassen O, Schommer K, Schmidt ME, Ulrich CM, Wiskemann J, Steindorf K. Exercise training intensity prescription in breast cancer survivors: validity of current practice and specific recommendations. J Cancer Surviv. 2015 — View Citation

Schmidt ME, Meynköhn A, Habermann N, Wiskemann J, Oelmann J, Hof H, Wessels S, Klassen O, Debus J, Potthoff K, Steindorf K, Ulrich CM. Resistance Exercise and Inflammation in Breast Cancer Patients Undergoing Adjuvant Radiation Therapy: Mediation Analysis — View Citation

Schmidt ME, Semik J, Habermann N, Wiskemann J, Ulrich CM, Steindorf K. Cancer-related fatigue shows a stable association with diurnal cortisol dysregulation in breast cancer patients. Brain Behav Immun. 2016 Feb;52:98-105. doi: 10.1016/j.bbi.2015.10.005. — View Citation

Steindorf K, Schmidt ME, Klassen O, Ulrich CM, Oelmann J, Habermann N, Beckhove P, Owen R, Debus J, Wiskemann J, Potthoff K. Randomized, controlled trial of resistance training in breast cancer patients receiving adjuvant radiotherapy: results on cancer-r — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigue measured by Fatigue Assessment Questionnaire (FAQ) change between baseline and week 13 (end of intervention) No
Secondary Quantity of FoxP3+ CD25+ regulatory T-cells change between baseline and week 13 (end of intervention) No
Secondary Inflammatory parameter CRP, SAA and IL-6 change between baseline and week 13 (end of intervention) No
Secondary Circulating lymphocytes subpopulations (CD4+, CD8+, CD56+) change between baseline and week 13 (end of intervention) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary Muscle strength measured at the IsoMed2000® change between baseline and week 13 (end of intervention) No
Secondary Cardiorespiratory fitness measured by ergospirometry change between baseline and week 13 (end of intervention) No
Secondary 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 Yes
Secondary Cognitive performance measured by the Trail-Making-Test change between baseline and week 13 (end of intervention) No
Secondary 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 No
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