NCT01468766

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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

2.4 years

First QC Date

October 11, 2011

Last Update Submit

April 18, 2016

Conditions

Breast CancerCancer-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 (11)

  • Quantity of FoxP3+ CD25+ regulatory T-cells

    change between baseline and week 13 (end of intervention)

  • Inflammatory parameter CRP, SAA and IL-6

    change between baseline and week 13 (end of intervention)

  • Circulating lymphocytes subpopulations (CD4+, CD8+, CD56+)

    change between baseline and week 13 (end of intervention)

  • Specificity of FoxP3+ CD25+ regulatory T-cells (in a subgroup only)

    change between baseline and week 13 (end of intervention)

  • 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)

  • +6 more secondary outcomes

Study Arms (2)

Resistance training

ACTIVE COMPARATOR
Other: Supervised progressive resistance training

Relaxation training

ACTIVE COMPARATOR
Other: Supervised progressive muscle relaxation training (Jacobson method)

Interventions

Supervised progressive resistance trainingOTHER

2x60 minutes per week for 12 weeks

Resistance training
Supervised progressive muscle relaxation training (Jacobson method)OTHER

2x60 minutes per week for 12 weeks

Relaxation training

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • contraindication for exercise
  • participation in the BEATE trial or another systematic resistance or relaxation training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center for Tumor Diseases

Heidelberg, 69120, Germany

Location

Related Publications (11)

  • 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.

    PMID: 23537231BACKGROUND

  • 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.

    PMID: 25096607RESULT

  • 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: 24837860RESULT

  • 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.

    PMID: 26853341RESULT

  • 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.

    PMID: 25885634RESULT

  • 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: 25711667RESULT

  • 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.

    PMID: 26456694RESULT

  • 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: 39656317DERIVED

  • 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: 39606939DERIVED

  • 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.

    PMID: 37337948DERIVED

  • 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.

    PMID: 28181128DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Karen Steindorf, Prof. Dr.

    German Cancer Research Center

    PRINCIPAL INVESTIGATOR

  • Karin Potthoff, Dr.

    University Hospital 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
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Karen Steindorf / Dr. Karin Potthoff, National Center for Tumor Diseases, Heidelberg

Study Record Dates

First Submitted

October 11, 2011

First Posted

November 9, 2011

Study Start

February 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2014

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

DE(1)