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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

NCT ID: NCT01106820

Last Updated: 2016-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Breast Cancer Cancer-related Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Resistance training

Group Type ACTIVE_COMPARATOR

Supervised progressive resistance training

Intervention Type OTHER

Supervised progressive resistance training

Relaxation training

Group Type ACTIVE_COMPARATOR

Supervised progressive muscle relaxation training (Jacobsen method)

Intervention Type OTHER

Supervised progressive muscle relaxation training (Jacobsen method)

Interventions

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Supervised progressive resistance training

Supervised progressive resistance training

Intervention Type OTHER

Supervised progressive muscle relaxation training (Jacobsen method)

Supervised progressive muscle relaxation training (Jacobsen method)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Center for Tumor Diseases, Heidelberg

OTHER

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role collaborator

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role collaborator

German Cancer Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Steindorf, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

NCT Heidelberg

Locations

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German Cancer Research Center

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 23103936 (View on PubMed)

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.

Reference Type RESULT
PMID: 25484317 (View on PubMed)

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.

Reference Type RESULT
PMID: 24837860 (View on PubMed)

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.

Reference Type RESULT
PMID: 25711667 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39656317 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39606939 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29445858 (View on PubMed)

Other Identifiers

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BEATE-1

Identifier Type: -

Identifier Source: org_study_id