Breast CancerBENEFITNCT02999074
Exercise Interventions for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
A study testing Resistance exercise and Aerobic exercise in people with Breast Cancer, run by German Cancer Research Center at 1 site in Germany.
Trial summary
The BENEFIT-Study is a randomized controlled 3-arm intervention trial investigating the currently discussed hypothesis that exercise concomitant to chemotherapy (CTx) may have a beneficial effect on cancer prognosis by boosting the anti-tumoral effect of the cytostatics or by enhancing therapy compliance. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Resistance exercise and Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jan 2016to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women ≥ 18 years of Age
- Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy
- Scheduled for neoadjuvant CTx (but not yet started)
- Confirmed hormone receptor and Her2 status
- Sufficient German language skills
- Willing to train at the exercise facilities twice per week
Who cannot join
- Any physical or mental conditions that would hamper the adherence to the training programs or the completion of the study procedures
- Engaging in systematic intense exercise training (at least 1h twice per week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized 3-arm Exercise Intervention Trial for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
The BENEFIT-Study is a randomized controlled 3-arm intervention trial investigating the currently discussed hypothesis that exercise concomitant to chemotherapy (CTx) may have a beneficial effect on cancer prognosis by boosting the anti-tumoral effect of the cytostatics or by enhancing therapy compliance. This hypothesis is based on pre-clinical and exploratory clinical trials. Breast cancer patients scheduled for neoadjuvant CTx will be randomized to either a resistance training or an aerobic training concomitant to the neoadjuvant CTx, or a waiting list control group that will get no exercise intervention during neoadjuvant CTx (i.e. usual care) but will exercise after breast surgery. The primary study endpoint is the tumor size. Further, the effects of resistance and aerobic exercise on the clinical-pathologic stage (CPS-EG) score, the pathological complete response (pCR), tolerability and compliance to CTx, physical fitness, patient reported outcomes such as fatigue, sleep problems, quality of life, depressive symptoms, anxiety and pain, as well as cognitive function, and selected biomarkers will be investigated.
A confirmation of the study hypothesis would be a strong argument for patients to engage in exercise as early as during neoadjuvant CTx. The trial will also provide evidence-based guidance for patients regarding type and timing of training.
- Conditions
- Breast Cancer
- Being tested
- Resistance exercise, Aerobic exercise, Usual care during neoadjuvant chemotherapy/Exercise after surgery
- Keywords
- exercise, resistance training, aerobic training, breast cancer, neoadjuvant chemotherapy, fatigue, quality of life, tumor response
- Medical subject headings
- Breast Neoplasms, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseOther
The training will take place twice weekly over the course of neoadjuvant CTx at the NCT Heidelberg or in regional qualified centers under supervision and guidance of experienced exercise therapists. The progressive resistance exercise comprises 8 machine-based exercises, each performed in 3 sets, 12 repetitions at 60-80% of one repetition maximum (1-RM).
Aerobic exerciseOther
The training will take place twice weekly over the course of neoadjuvant CTx at the NCT Heidelberg or in regional qualified centers under supervision and guidance of experienced exercise therapists. The aerobic exercise will be performed on a cycle ergometer (or alternatively at a treadmill, elliptical, rowing ergometer, or combination) progressing from 60% to 70% VO2max with increasing duration. During weeks 7-18 the goal is to perform an extensive interval training.
Usual care during neoadjuvant chemotherapy/Exercise after surgeryOther
The control group receives no exercise intervention during neoadjuvant CTx, which reflects the usual care condition. To investigate effects of different exercise timing, and to provide those patients also a potential health benefit and reduce drop-out and contamination, the control group will receive 18 weeks resistance or aerobic exercise (according to their personal preferences) after breast cancer surgery.
| Study group | Role | What they receive |
|---|---|---|
| Resistance exercise | Active comparator | Not described Receives: Other: Resistance exercise |
| Aerobic exercise | Active comparator | Not described Receives: Other: Aerobic exercise |
| Waitlist control | Other | Not described Receives: Other: Usual care during neoadjuvant chemotherapy/Exercise after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor size
percentage of change from the maximal diameter of the lesion assessed before neoadjuvant chemotherapy (by mammography or sonography) to the maximal diameter of the tumor assessed after neoadjuvant chemotherapy at breast surgery
Measured: change from baseline (before start of neoadjuvant chemotherapy) to breast surgery
Secondary outcomes (15)
CPS-EG score
The Clinical-Pathologic Stage (CPS-EG) score combines clinical tumor stage prior to neoadjuvant therapy (CS), pathological tumor stage after neoadjuvant treatment (PS), estrogen receptor status (E) and grading (G). It has been shown to be a valid prognostic factor to discriminate among patient subgroups with respect to survival after neoadjuvant CTx.
Measured: at breast surgery
pCR
The Pathological Complete Response (pCR) is defined as ypT0/is ypN0 and has been consistently demonstrated to be a good prognostic factor for long-term benefit from neoadjuvant CTx.
Measured: at breast surgery
Fatigue Assessment Questionnaire (FAQ)
Validated 20-item multidimensional self-assessment questionnaire to assess the physical, affective, and cognitive dimension of cancer-related fatigue
Measured: at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery
EORTC QLQ-C30 / BR23
Validated 30-item self-assessment questionnaire to assess quality of life aspects.
Measured: at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
A validated 4-item screener for depression and anxiety.
Measured: at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery
Pittsburgh Sleep Quality Index (PSQI)
Validated questionnaire to assess sleep quality and sleep problems.
Measured: at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery
Spiroergometry (VO2max)
Measured: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Isometric and isokinetic muscle strength measured by ISOMED 2000
Measured: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Body mass index
Measured: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Self-developed physical activity questionnaire including type, duration, frequency and intensity of sports, cycling,and walking
Measured: Follow-up (6 months and 12 months after breast surgery)
Cognitive function - HVLT-R
Hopkins Verbal Learning Test - Revised (HVLT-R)
Measured: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Cognitive function - TMT
Trail Making Test
Measured: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Cognitive function - COWA
Controlled Oral Word Association
Measured: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Sleep quality
Measured with ActiGraph (accelerometry)
Measured: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Sleep efficiency
Measured with ActiGraph (accelerometry)
Measured: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start22 Jan 2016
- Primary completion29 Jun 2023
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999074
- Sponsor's protocol ID
- BENEFIT
- Acronym
- BENEFIT
- Status last verified
- Dec 2024
- First submitted
- 6 May 2016
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Haussmann A, Schmidt ME, Goldschmidt S, Hiensch AE, Wiskemann J, Steindorf K. Effects of aerobic or resistance exercise on sleep and cancer-related fatigue in patients with breast cancer during or after neoadjuvant chemotherapy: a 3-arm randomized controlled trial. BMC Med. 2026 Jan 28;24(1):114. doi: 10.1186/s12916-026-04669-3.
PubMed 41593692Ernst 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 39606939Goldschmidt S, Schmidt ME, Rosenberger F, Wiskemann J, Steindorf K. Patterns and influencing factors of exercise attendance of breast cancer patients during neoadjuvant chemotherapy. Support Care Cancer. 2024 Jan 3;32(1):79. doi: 10.1007/s00520-023-08269-2.
PubMed 38170301Kreutz C, Muller J, Schmidt ME, Steindorf K. Comparison of subjectively and objectively assessed sleep problems in breast cancer patients starting neoadjuvant chemotherapy. Support Care Cancer. 2021 Feb;29(2):1015-1023. doi: 10.1007/s00520-020-05580-0. Epub 2020 Jun 19.
PubMed 32556623
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized 3-arm Exercise Intervention Trial for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT02999074
- Acronym / sponsor ID
- BENEFIT / BENEFIT
- Conditions
- Breast Cancer
- Keywords
- exercise, resistance training, aerobic training, breast cancer, neoadjuvant chemotherapy, fatigue, quality of life, tumor response
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 183 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg
- Study start
- 22 Jan 2016 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 21 Dec 2016 (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.
The BENEFIT-Study is a randomized controlled 3-arm intervention trial investigating the currently discussed hypothesis that exercise concomitant to chemotherapy (CTx) may have a beneficial effect on cancer prognosis by boosting the anti-tumoral effect of the cytostatics or by enhancing therapy compliance. This hypothesis is based on pre-clinical and exploratory clinical trials. Breast cancer patients scheduled for neoadjuvant CTx will be randomized to either a resistance training or an aerobic training concomitant to the neoadjuvant CTx, or a waiting list control group that will get no exercise intervention during neoadjuvant CTx (i.e. usual care) but will exercise after breast surgery. The primary study endpoint is the tumor size. Further, the effects of resistance and aerobic exercise on the clinical-pathologic stage (CPS-EG) score, the pathological complete response (pCR), tolerability and compliance to CTx, physical fitness, patient reported outcomes such as fatigue, sleep problems, quality of life, depressive symptoms, anxiety and pain, as well as cognitive function, and selected biomarkers will be investigated.
A confirmation of the study hypothesis would be a strong argument for patients to engage in exercise as early as during neoadjuvant CTx. The trial will also provide evidence-based guidance for patients regarding type and timing of training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance exercise | Active comparator | Other: Resistance exercise |
| Aerobic exercise | Active comparator | Other: Aerobic exercise |
| Waitlist control | Other | Other: Usual care during neoadjuvant chemotherapy/Exercise after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women ≥ 18 years of Age
- Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy
- Scheduled for neoadjuvant CTx (but not yet started)
- Confirmed hormone receptor and Her2 status
- Sufficient German language skills
Key exclusion criteria (2 listed)
- Any physical or mental conditions that would hamper the adherence to the training programs or the completion of the study procedures
- Engaging in systematic intense exercise training (at least 1h twice per week)
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 |
|---|---|---|
| Resistance exerciseThe training will take place twice weekly over the course of neoadjuvant CTx at the NCT Heidelberg or in regional qualified centers under supervision and guidance of experienced exercise therapists. The progressive resistance exercise comprises 8 machine-based exercises, each performed in 3 sets, 12 repetitions at 60-80% of one repetition maximum (1-RM). | Other | Resistance exercise |
| Aerobic exerciseThe training will take place twice weekly over the course of neoadjuvant CTx at the NCT Heidelberg or in regional qualified centers under supervision and guidance of experienced exercise therapists. The aerobic exercise will be performed on a cycle ergometer (or alternatively at a treadmill, elliptical, rowing ergometer, or combination) progressing from 60% to 70% VO2max with increasing duration. During weeks 7-18 the goal is to perform an extensive interval training. | Other | Aerobic exercise |
| Usual care during neoadjuvant chemotherapy/Exercise after surgeryThe control group receives no exercise intervention during neoadjuvant CTx, which reflects the usual care condition. To investigate effects of different exercise timing, and to provide those patients also a potential health benefit and reduce drop-out and contamination, the control group will receive 18 weeks resistance or aerobic exercise (according to their personal preferences) after breast cancer surgery. | Other | Waitlist control |
Primary outcome
Tumor size
Time frame: change from baseline (before start of neoadjuvant chemotherapy) to breast surgery
percentage of change from the maximal diameter of the lesion assessed before neoadjuvant chemotherapy (by mammography or sonography) to the maximal diameter of the tumor assessed after neoadjuvant chemotherapy at breast surgery
15 secondary outcomes
CPS-EG score
Time frame: at breast surgery
pCR
Time frame: at breast surgery
Fatigue Assessment Questionnaire (FAQ)
Time frame: at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery
EORTC QLQ-C30 / BR23
Time frame: at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
Time frame: at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery
Pittsburgh Sleep Quality Index (PSQI)
Time frame: at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery
Spiroergometry (VO2max)
Time frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Isometric and isokinetic muscle strength measured by ISOMED 2000
Time frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Body mass index
Time frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Self-developed physical activity questionnaire including type, duration, frequency and intensity of sports, cycling,and walking
Time frame: Follow-up (6 months and 12 months after breast surgery)
Cognitive function - HVLT-R
Time frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Cognitive function - TMT
Time frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Cognitive function - COWA
Time frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Sleep quality
Time frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Sleep efficiency
Time frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Derived from this study: PubMed 41593692Haussmann A, Schmidt ME, Goldschmidt S, Hiensch AE, Wiskemann J, Steindorf K. Effects of aerobic or resistance exercise on sleep and cancer-related fatigue in patients with breast cancer during or after neoadjuvant chemotherapy: a 3-arm randomized controlled trial. BMC Med. 2026 Jan 28;24(1):114. doi: 10.1186/s12916-026-04669-3.
- 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 38170301Goldschmidt S, Schmidt ME, Rosenberger F, Wiskemann J, Steindorf K. Patterns and influencing factors of exercise attendance of breast cancer patients during neoadjuvant chemotherapy. Support Care Cancer. 2024 Jan 3;32(1):79. doi: 10.1007/s00520-023-08269-2.
- Derived from this study: PubMed 32556623Kreutz C, Muller J, Schmidt ME, Steindorf K. Comparison of subjectively and objectively assessed sleep problems in breast cancer patients starting neoadjuvant chemotherapy. Support Care Cancer. 2021 Feb;29(2):1015-1023. doi: 10.1007/s00520-020-05580-0. Epub 2020 Jun 19.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise and Aerobic exercise in people with Breast Cancer, run by German Cancer Research Center at 1 site in Germany.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Tumor size (time frame: change from baseline (before start of neoadjuvant chemotherapy) to breast surgery). 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 NCT02999074, which also lists 4 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 11 Dec 2024.