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

Breast Cancer Clinical Trial

— BEATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106820
• Other study ID #: BEATE-1
• Status: Completed
• Phase: N/A
• First received: April 14, 2010
• Last updated: December 16, 2016
• Start date: April 2010
• Est. completion date: October 2014

Study information

• Verified date: December 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer-related Fatigue
• Fatigue

Intervention

Other:
• Supervised progressive resistance training
Supervised progressive resistance training
• Supervised progressive muscle relaxation training (Jacobsen method)
Supervised progressive muscle relaxation training (Jacobsen method)

Locations

Country	Name	City	State
Germany	German Cancer Research Center	Heidelberg

Sponsors (4)

Lead Sponsor	Collaborator
German Cancer Research Center	Central Institute of Mental Health, Mannheim, National Center for Tumor Diseases, Heidelberg, University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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

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, Wiskemann J, Armbrust P, Schneeweiss A, Ulrich CM, Steindorf K. Effects of resistance exercise on fatigue and quality of life in breast cancer patients undergoing adjuvant chemotherapy: A randomized controlled trial. Int J Cancer. 2015 Jul 15; — View Citation

Schmidt ME, Wiskemann J, Krakowski-Roosen H, Knicker AJ, Habermann N, Schneeweiss A, Ulrich CM, Steindorf K. Progressive resistance versus relaxation training for breast cancer patients during adjuvant chemotherapy: design and rationale of a randomized controlled trial (BEATE study). Contemp Clin Trials. 2013 Jan;34(1):117-25. doi: 10.1016/j.cct.2012.10.006. — 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	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	Biomarker in blood, urine, and saliva		change between baseline and week 6 and 13	No
Secondary	Number of patients with adverse events potentially related to the resistance training		during the 12-week exercise intervention	Yes