Clinical trial NCT01106820: Progressive Resistance Training Versus Relaxation for Breast Cancer Patients During Chemotherapy: Biological Mechanisms and Effects on Fatigue and Quality of Life
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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cancer-related Fatigue
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: National Center for Tumor Diseases, Heidelberg
name: University Hospital Heidelberg
name: Central Institute of Mental Health, Mannheim
First posted: 2010-04-20
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
timeFrame: change between baseline and week 13 (end of intervention)
Secondary outcomes:
measure: Quality of Life measured by the European Organisation for Research and Treatment of Cancer questionnaire (EORTC-QLQ30/BR23)
timeFrame: change between baseline and week 13 (end of intervention)
measure: Depression measured by "Allgemeine Depressionsskala" (ADS, the German version of the Center for Epidemiological Studies Depression Scale (CES-D))
timeFrame: change between baseline and week 13 (end of intervention)
measure: Muscle strength measured at the IsoMed2000®
timeFrame: change between baseline and week 13 (end of intervention)
measure: Cardiorespiratory fitness measured by ergospirometry
timeFrame: change between baseline and week 13 (end of intervention)
measure: Biomarker in blood, urine, and saliva
timeFrame: change between baseline and week 6 and 13
measure: Number of patients with adverse events potentially related to the resistance training
timeFrame: during the 12-week exercise intervention
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: German Cancer Research Center
Study officials:
affiliation: NCT Heidelberg
name: Karen Steindorf, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.