Exercise Interventions for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
NCT ID: NCT02999074
Last Updated: 2024-12-11
Study Results
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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ACTIVE_NOT_RECRUITING
NA
183 participants
INTERVENTIONAL
2016-01-22
2025-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Resistance exercise
Resistance exercise
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 exercise
Aerobic exercise
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.
Waitlist control
Usual care during neoadjuvant chemotherapy/Exercise after surgery
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.
Interventions
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Resistance exercise
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 exercise
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 surgery
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Engaging in systematic intense exercise training (at least 1h twice per week)
18 Years
FEMALE
No
Sponsors
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University Hospital Heidelberg
OTHER
German Cancer Research Center
OTHER
Responsible Party
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Locations
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National Center for Tumor Diseases (NCT)
Heidelberg, , Germany
Countries
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References
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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.
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.
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.
Other Identifiers
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BENEFIT
Identifier Type: -
Identifier Source: org_study_id