Back to resultsProgressive Resistance Training Versus Relaxation for Breast Cancer Patients During Chemotherapy: Biological Mechanisms and Effects on Fatigue and Quality of Life (BEATE)
Primary Purpose
Breast Cancer, Cancer-related Fatigue
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Supervised progressive resistance training
Supervised progressive muscle relaxation training (Jacobsen method)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- German Cancer Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Resistance training
Relaxation training
Arm Description
Outcomes
Primary Outcome Measures
Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
Secondary Outcome Measures
Quality of Life measured by the European Organisation for Research and Treatment of Cancer questionnaire (EORTC-QLQ30/BR23)
Depression measured by "Allgemeine Depressionsskala" (ADS, the German version of the Center for Epidemiological Studies Depression Scale (CES-D))
Muscle strength measured at the IsoMed2000®
Cardiorespiratory fitness measured by ergospirometry
Biomarker in blood, urine, and saliva
Number of patients with adverse events potentially related to the resistance training
Full Information
NCT ID
NCT01106820
First Posted
April 14, 2010
Last Updated
December 16, 2016
Sponsor
German Cancer Research Center
Collaborators
National Center for Tumor Diseases, Heidelberg, University Hospital Heidelberg, Central Institute of Mental Health, Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT01106820
Brief Title
Progressive Resistance Training Versus Relaxation for Breast Cancer Patients During Chemotherapy: Biological Mechanisms and Effects on Fatigue and Quality of Life
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Cancer Research Center
Collaborators
National Center for Tumor Diseases, Heidelberg, University Hospital Heidelberg, Central Institute of Mental Health, Mannheim
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer-related Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resistance training
Arm Type
Active Comparator
Arm Title
Relaxation training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Supervised progressive resistance training
Intervention Description
Supervised progressive resistance training
Intervention Type
Other
Intervention Name(s)
Supervised progressive muscle relaxation training (Jacobsen method)
Intervention Description
Supervised progressive muscle relaxation training (Jacobsen method)
Primary Outcome Measure Information:
Title
Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
Time Frame
change between baseline and week 13 (end of intervention)
Secondary Outcome Measure Information:
Title
Quality of Life measured by the European Organisation for Research and Treatment of Cancer questionnaire (EORTC-QLQ30/BR23)
Time Frame
change between baseline and week 13 (end of intervention)
Title
Depression measured by "Allgemeine Depressionsskala" (ADS, the German version of the Center for Epidemiological Studies Depression Scale (CES-D))
Time Frame
change between baseline and week 13 (end of intervention)
Title
Muscle strength measured at the IsoMed2000®
Time Frame
change between baseline and week 13 (end of intervention)
Title
Cardiorespiratory fitness measured by ergospirometry
Time Frame
change between baseline and week 13 (end of intervention)
Title
Biomarker in blood, urine, and saliva
Time Frame
change between baseline and week 6 and 13
Title
Number of patients with adverse events potentially related to the resistance training
Time Frame
during the 12-week exercise intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Steindorf, Prof. Dr.
Organizational Affiliation
NCT Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Cancer Research Center
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23103936
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. Epub 2012 Oct 25.
Results Reference
background
PubMed Identifier
25484317
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;137(2):471-80. doi: 10.1002/ijc.29383. Epub 2014 Dec 16.
Results Reference
result
PubMed Identifier
24837860
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: 10.3109/0284186X.2014.899435. Epub 2014 May 16.
Results Reference
result
PubMed Identifier
25711667
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 Dec;9(4):612-9. doi: 10.1007/s11764-015-0437-z. Epub 2015 Feb 26.
Results Reference
result
PubMed Identifier
29445858
Citation
Schmidt ME, Wiskemann J, Johnson T, Habermann N, Schneeweiss A, Steindorf K. L-Thyroxine intake as a potential risk factor for the development of fatigue in breast cancer patients undergoing chemotherapy. Support Care Cancer. 2018 Aug;26(8):2561-2569. doi: 10.1007/s00520-018-4095-3. Epub 2018 Feb 14.
Results Reference
derived
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Progressive Resistance Training Versus Relaxation for Breast Cancer Patients During Chemotherapy: Biological Mechanisms and Effects on Fatigue and Quality of Life
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