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

Breast Cancer Clinical Trial

— BEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468766
• Other study ID #: BEST
• 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

• Breast Cancer
• Breast Neoplasms
• Cancer-related Fatigue

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