Exercise Interventions for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy

NCT02999074 | Active Not Recruiting

• 1 other identifier: BENEFIT
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

exercise; resistance training; aerobic training; breast cancer; neoadjuvant chemotherapy; fatigue; quality of life; tumor response

Outcome Measures

Primary Outcomes (1)

• 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

  change from baseline (before start of neoadjuvant chemotherapy) to breast surgery

Secondary Outcomes (15)

• CPS-EG score

  at breast surgery

• pCR

  at breast surgery

• Fatigue Assessment Questionnaire (FAQ)

  at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery

• EORTC QLQ-C30 / BR23

  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)

  at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery

Study Arms (3)

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

Interventions

Resistance exercise OTHER

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).

Resistance exercise

Aerobic exercise OTHER

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.

Aerobic exercise

Usual care during neoadjuvant chemotherapy/Exercise after surgery OTHER

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.

Waitlist control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• German Cancer Research Center: lead
• University Hospital Heidelberg: collaborator

Study Sites (1)

National Center for Tumor Diseases (NCT)

Heidelberg, 69120, Germany

Location

Related Publications (4)

• 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. doi: 10.1186/s12916-026-04669-3. Online ahead of print.

  PMID: 41593692 DERIVED

• 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: 39606939 DERIVED

• Goldschmidt 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.

  PMID: 38170301 DERIVED

• Kreutz 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.

  PMID: 32556623 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Fatigue

Interventions

Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: December 21, 2016
• Study Start: January 22, 2016
• Primary Completion: June 29, 2023
• Study Completion: September 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)