Breast CancerBESTNCT01468766

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

A study testing Supervised progressive resistance training and Supervised progressive muscle relaxation training (Jacobson method) in people with Breast Cancer and Cancer-related Fatigue, run by German Cancer Research Center at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Cancer-related Fatigue
What is being tested?: Supervised progressive resistance training and Supervised progressive muscle relaxation training (Jacobson method)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 siteGermany
Study dates: Feb 2011to Jul 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

National Center for Tumor Diseases
Heidelberg, 69120

Other trials in Germany

About this study

Official title: Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy - A Randomised Controlled Intervention Trial

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).

Conditions: Breast Cancer, Cancer-related Fatigue
Being tested: Supervised progressive resistance training, Supervised progressive muscle relaxation training (Jacobson method)
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Supervised progressive resistance trainingOther
2x60 minutes per week for 12 weeks
Supervised progressive muscle relaxation training (Jacobson method)Other
2x60 minutes per week for 12 weeks

Study groups in NCT01468766
Study group	Role	What they receive
Resistance training	Active comparator	Not described Receives: Other: Supervised progressive resistance training
Relaxation training	Active comparator	Not described Receives: Other: Supervised progressive muscle relaxation training (Jacobson method)

What is being measured

The primary outcome is the main question the study is designed to answer.

Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
Measured: change between baseline and week 13 (end of intervention)

Secondary outcomes (11)

Quantity of FoxP3+ CD25+ regulatory T-cells
Measured: change between baseline and week 13 (end of intervention)
Inflammatory parameter CRP, SAA and IL-6
Measured: change between baseline and week 13 (end of intervention)
Circulating lymphocytes subpopulations (CD4+, CD8+, CD56+)
Measured: change between baseline and week 13 (end of intervention)
Specificity of FoxP3+ CD25+ regulatory T-cells (in a subgroup only)
immunmagnetic purification of the Treg (Selection by CD4 und CD25 expression; MACS-beads) by co-culturing of titrated Treg with 3H marked autologuous, polyclonal (anti CD3/CD28) activiated, conventional T-cells (CD4+, CD25+) and subsequent assessment of the proliferation of conventional T-cells.
Zur Bestimmung der Treg-Spezifität wurde eigens eine neue Methode entwickelt, die auf der signifikant erhöhten suppressiven Aktivität antigenspezifisch aktivierter Treg, gegenüber nicht aktivierten Treg, basiert.
Measured: 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)
Measured: 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))
Measured: change between baseline and week 13 (end of intervention)
Muscle strength measured at the IsoMed2000®
Measured: change between baseline and week 13 (end of intervention)
Cardiorespiratory fitness measured by ergospirometry
Measured: change between baseline and week 13 (end of intervention)
Number of participants with lymphedema, pain, nausea, dyspnea, or tachycardia as a measure of safety of resistance training during radiotherapy.
Measured: events with onset or worsening during the 12-week intervention period are considered
Cognitive performance measured by the Trail-Making-Test
Measured: change between baseline and week 13 (end of intervention)
Toxicity of radiotherapy (acute radio dermatitis; LENT-SOMA classification for late effects)
Measured: acute toxicity during radio therapy and late effects 6 weeks after end of radio therapy are recorded

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Jul 2014

First posted9 Nov 2011 (estimated)
Study startFeb 2011
Primary completionJul 2013
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01468766
Sponsor's protocol ID: BEST
Acronym: BEST
Status last verified: Apr 2016
First submitted: 11 Oct 2011
Last updated: 19 Apr 2016
Results posted: No

Publications

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.
PubMed 23537231
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.
PubMed 25096607
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.
PubMed 24837860
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.
PubMed 26853341
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.
PubMed 25885634
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.
PubMed 25711667
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.
PubMed 26456694
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.
PubMed 39656317
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.
PubMed 39606939
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.
PubMed 37337948
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.
PubMed 28181128

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy - A Randomised Controlled Intervention Trial
ClinicalTrials.gov ID: NCT01468766
Acronym / sponsor ID: BEST / BEST
Conditions: Breast Cancer, Cancer-related Fatigue
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: German Cancer Research CenterUniversity, hospital or other
Collaborators: University Hospital Heidelberg, National Center for Tumor Diseases, Heidelberg
Study start: Feb 2011
Primary completion: Jul 2013 (actual)
Study completion: Jul 2014 (actual)
First posted: 9 Nov 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Resistance training	Active comparator	Other: Supervised progressive resistance training
Relaxation training	Active comparator	Other: Supervised progressive muscle relaxation training (Jacobson method)

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Supervised progressive resistance training2x60 minutes per week for 12 weeks	Other	Resistance training
Supervised progressive muscle relaxation training (Jacobson method)2x60 minutes per week for 12 weeks	Other	Relaxation training

Primary outcome

Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
Time frame: change between baseline and week 13 (end of intervention)

11 secondary outcomes

Quantity of FoxP3+ CD25+ regulatory T-cells
Time frame: change between baseline and week 13 (end of intervention)
Inflammatory parameter CRP, SAA and IL-6
Time frame: change between baseline and week 13 (end of intervention)
Circulating lymphocytes subpopulations (CD4+, CD8+, CD56+)
Time frame: change between baseline and week 13 (end of intervention)
Specificity of FoxP3+ CD25+ regulatory T-cells (in a subgroup only)
Time frame: 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)
Time frame: 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))
Time frame: change between baseline and week 13 (end of intervention)
Muscle strength measured at the IsoMed2000®
Time frame: change between baseline and week 13 (end of intervention)
Cardiorespiratory fitness measured by ergospirometry
Time frame: change between baseline and week 13 (end of intervention)
Number of participants with lymphedema, pain, nausea, dyspnea, or tachycardia as a measure of safety of resistance training during radiotherapy.
Time frame: events with onset or worsening during the 12-week intervention period are considered
Cognitive performance measured by the Trail-Making-Test
Time frame: change between baseline and week 13 (end of intervention)
Toxicity of radiotherapy (acute radio dermatitis; LENT-SOMA classification for late effects)
Time frame: acute toxicity during radio therapy and late effects 6 weeks after end of radio therapy are recorded

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
Background: PubMed 23537231Potthoff 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.
Results publication: PubMed 25096607Steindorf 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.
Results publication: PubMed 24837860Klassen 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.
Results publication: PubMed 26853341Schmidt 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.
Results publication: PubMed 25885634Gollhofer 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.
Results publication: PubMed 25711667Scharhag-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.
Results publication: PubMed 26456694Schmidt 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.
Derived from this study: PubMed 39656317Koeppel 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.
Derived from this study: PubMed 39606939Ernst 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.
Derived from this study: PubMed 37337948Schmidt 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.
Derived from this study: PubMed 28181128Steindorf 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.

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RecruitingPhase 2
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karen Steindorf, Prof. Dr. principal investigator

German Cancer Research Center

Karin Potthoff, Dr. principal investigator

University Hospital Heidelberg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue measured by Fatigue Assessment Questionnaire (FAQ) (time frame: change between baseline and week 13 (end of intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01468766, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.