Exercise Interventions for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
- Conditions
- Breast Cancer
- Interventions
- Other: Resistance exerciseOther: Usual care during neoadjuvant chemotherapy/Exercise after surgeryOther: Aerobic exercise
- Registration Number
- NCT02999074
- Lead Sponsor
- German Cancer Research Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 183
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Resistance exercise Resistance exercise - Waitlist control Usual care during neoadjuvant chemotherapy/Exercise after surgery - Aerobic exercise Aerobic exercise -
- Primary Outcome Measures
Name Time Method Tumor size 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
- Secondary Outcome Measures
Name Time Method CPS-EG score at breast surgery 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.
Body mass index 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 Follow-up (6 months and 12 months after breast surgery) Cognitive function - TMT at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery Trail Making Test
Cognitive function - COWA at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery Controlled Oral Word Association
Sleep quality at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery Measured with ActiGraph (accelerometry)
pCR at breast surgery 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.
Cognitive function - HVLT-R at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery Hopkins Verbal Learning Test - Revised (HVLT-R)
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 A validated 4-item screener for depression and anxiety.
Pittsburgh Sleep Quality Index (PSQI) at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery Validated questionnaire to assess sleep quality and sleep problems.
Sleep efficiency at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery Measured with ActiGraph (accelerometry)
Fatigue Assessment Questionnaire (FAQ) at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery Validated 20-item multidimensional self-assessment questionnaire to assess the physical, affective, and cognitive dimension of cancer-related fatigue
EORTC QLQ-C30 / BR23 at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery Validated 30-item self-assessment questionnaire to assess quality of life aspects.
Spiroergometry (VO2max) at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery Isometric and isokinetic muscle strength measured by ISOMED 2000 at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Trial Locations
- Locations (1)
National Center for Tumor Diseases (NCT)
🇩🇪Heidelberg, Germany