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

NCT01106820 | Completed

• 1 other identifier: BEATE-1
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer; Cancer-related Fatigue

Outcome Measures

Primary Outcomes (1)

• Fatigue measured by Fatigue Assessment Questionnaire (FAQ)

  change between baseline and week 13 (end of intervention)

Secondary Outcomes (6)

• 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)

• 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)

• Muscle strength measured at the IsoMed2000®

  change between baseline and week 13 (end of intervention)

• Cardiorespiratory fitness measured by ergospirometry

  change between baseline and week 13 (end of intervention)

• Biomarker in blood, urine, and saliva

  change between baseline and week 6 and 13

Study Arms (2)

Resistance training

ACTIVE COMPARATOR

Other: Supervised progressive resistance training

Relaxation training

ACTIVE COMPARATOR

Other: Supervised progressive muscle relaxation training (Jacobsen method)

Interventions

Supervised progressive resistance training OTHER

Supervised progressive resistance training

Resistance training

Supervised progressive muscle relaxation training (Jacobsen method) OTHER

Supervised progressive muscle relaxation training (Jacobsen method)

Relaxation training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• breast cancer patient after lumpectomy or mastectomy, stage I-III
• adjuvant chemotherapy
• BMI at least 18

You may not qualify if:

• contraindication for exercise
• radiotherapy during intervention period

Sponsors & Collaborators

• German Cancer Research Center: lead
• National Center for Tumor Diseases, Heidelberg: collaborator
• University Hospital Heidelberg: collaborator
• Central Institute of Mental Health, Mannheim: collaborator

Study Sites (1)

German Cancer Research Center

Heidelberg, 69120, Germany

Location

Related Publications (7)

• 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.

  PMID: 23103936 BACKGROUND

• 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.

  PMID: 25484317 RESULT

• 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.

  PMID: 24837860 RESULT

• 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.

  PMID: 25711667 RESULT

• Koeppel M, Steindorf K, Schmidt ME, Rosenberger F, Wiskemann J. Variability in resistance training trajectories of breast cancer patients undergoing therapy. Support Care Cancer. 2024 Dec 10;33(1):12. doi: 10.1007/s00520-024-09001-4.

  PMID: 39656317 DERIVED

• Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.

  PMID: 39606939 DERIVED

• 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.

  PMID: 29445858 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Karen Steindorf, Prof. Dr.

  NCT Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 20, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: December 19, 2016

Record last verified: 2016-12

Locations

DE (1)