Clinical trial NCT02999074: Exercise Interventions for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
Official title: A Randomized 3-arm Exercise Intervention Trial for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: exercise
resistance training
aerobic training
breast cancer
neoadjuvant chemotherapy
fatigue
quality of life
tumor response
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: University Hospital Heidelberg
First posted: 2016-12-21
Enrollment: 183
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Tumor size
timeFrame: change from baseline (before start of neoadjuvant chemotherapy) to breast surgery
Secondary outcomes:
measure: CPS-EG score
timeFrame: at breast surgery
measure: pCR
timeFrame: at breast surgery
measure: Fatigue Assessment Questionnaire (FAQ)
timeFrame: at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery
measure: EORTC QLQ-C30 / BR23
timeFrame: at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery
measure: Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
timeFrame: at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery
measure: Spiroergometry (VO2max)
timeFrame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
measure: Isometric and isokinetic muscle strength measured by ISOMED 2000
timeFrame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
measure: Body mass index
timeFrame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
measure: Self-developed physical activity questionnaire including type, duration, frequency and intensity of sports, cycling,and walking
timeFrame: Follow-up (6 months and 12 months after breast surgery)
measure: Cognitive function - HVLT-R
timeFrame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
measure: Cognitive function - TMT
timeFrame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
measure: Cognitive function - COWA
timeFrame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
measure: Sleep quality
timeFrame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
measure: Sleep efficiency
timeFrame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: National Center for Tumor Diseases (NCT)
Study officials:
References:
citation: 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.