Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy

NCT ID: NCT01468766

Last Updated: 2016-04-19

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-07-31

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 immunological and inflammatory biomarkers in breast cancer patients during adjuvant radiotherapy. 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

2x60 minutes per week for 12 weeks

Relaxation training

Group Type ACTIVE_COMPARATOR

Supervised progressive muscle relaxation training (Jacobson method)

Intervention Type OTHER

2x60 minutes per week for 12 weeks

Interventions

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Supervised progressive resistance training

2x60 minutes per week for 12 weeks

Intervention Type OTHER

Supervised progressive muscle relaxation training (Jacobson method)

2x60 minutes per week for 12 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* histologically confirmed primary breast cancer, stage I-III, after lumpectomy or mastectomy, indication for adjuvant radiotherapy
* BMI: 18-40
* ability to understand and follow the study protocol

Exclusion Criteria

* contraindication for exercise
* participation in the BEATE trial or another systematic resistance or relaxation training
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role collaborator

National Center for Tumor Diseases, Heidelberg

OTHER

Sponsor Role collaborator

German Cancer Research Center

OTHER

Sponsor Role lead

Responsible Party

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Karen Steindorf

Prof. Dr. Karen Steindorf / Dr. Karin Potthoff, National Center for Tumor Diseases, Heidelberg

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Steindorf, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

German Cancer Research Center

Karin Potthoff, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

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National Center for Tumor Diseases

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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Potthoff K, Schmidt ME, Wiskemann J, Hof H, Klassen O, Habermann N, Beckhove P, Debus J, Ulrich CM, Steindorf K. Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study. BMC Cancer. 2013 Mar 28;13:162. doi: 10.1186/1471-2407-13-162.

Reference Type BACKGROUND
PMID: 23537231 (View on PubMed)

Steindorf K, Schmidt ME, Klassen O, Ulrich CM, Oelmann J, Habermann N, Beckhove P, Owen R, Debus J, Wiskemann J, Potthoff K. Randomized, controlled trial of resistance training in breast cancer patients receiving adjuvant radiotherapy: results on cancer-related fatigue and quality of life. Ann Oncol. 2014 Nov;25(11):2237-2243. doi: 10.1093/annonc/mdu374. Epub 2014 Aug 5.

Reference Type RESULT
PMID: 25096607 (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)

Schmidt ME, Meynkohn A, Habermann N, Wiskemann J, Oelmann J, Hof H, Wessels S, Klassen O, Debus J, Potthoff K, Steindorf K, Ulrich CM. Resistance Exercise and Inflammation in Breast Cancer Patients Undergoing Adjuvant Radiation Therapy: Mediation Analysis From a Randomized, Controlled Intervention Trial. Int J Radiat Oncol Biol Phys. 2016 Feb 1;94(2):329-37. doi: 10.1016/j.ijrobp.2015.10.058. Epub 2015 Nov 2.

Reference Type RESULT
PMID: 26853341 (View on PubMed)

Gollhofer SM, Wiskemann J, Schmidt ME, Klassen O, Ulrich CM, Oelmann J, Hof H, Potthoff K, Steindorf K. Factors influencing participation in a randomized controlled resistance exercise intervention study in breast cancer patients during radiotherapy. BMC Cancer. 2015 Mar 27;15:186. doi: 10.1186/s12885-015-1213-1.

Reference Type RESULT
PMID: 25885634 (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)

Schmidt ME, Semik J, Habermann N, Wiskemann J, Ulrich CM, Steindorf K. Cancer-related fatigue shows a stable association with diurnal cortisol dysregulation in breast cancer patients. Brain Behav Immun. 2016 Feb;52:98-105. doi: 10.1016/j.bbi.2015.10.005. Epub 2015 Oct 9.

Reference Type RESULT
PMID: 26456694 (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, Chong M, Klassen O, Wiskemann J, Steindorf K. Longitudinal associations of bioelectrical phase angle and fatigue in breast cancer patients. Int J Cancer. 2023 Sep 15;153(6):1192-1200. doi: 10.1002/ijc.34630. Epub 2023 Jun 20.

Reference Type DERIVED
PMID: 37337948 (View on PubMed)

Steindorf K, Wiskemann J, Ulrich CM, Schmidt ME. Effects of exercise on sleep problems in breast cancer patients receiving radiotherapy: a randomized clinical trial. Breast Cancer Res Treat. 2017 Apr;162(3):489-499. doi: 10.1007/s10549-017-4141-8. Epub 2017 Feb 8.

Reference Type DERIVED
PMID: 28181128 (View on PubMed)

Other Identifiers

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BEST

Identifier Type: -

Identifier Source: org_study_id

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