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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
183
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).
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.
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.
National Center for Tumor Diseases (NCT)
Heidelberg, Germany
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
Time frame: change from baseline (before start of neoadjuvant chemotherapy) to breast surgery
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
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)
A validated 4-item screener for depression and anxiety.
Time frame: 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.
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
Hopkins Verbal Learning Test - Revised (HVLT-R)
Time frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Cognitive function - TMT
Trail Making Test
Time frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Cognitive function - COWA
Controlled Oral Word Association
Time frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Sleep quality
Measured with ActiGraph (accelerometry)
Time frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
Sleep efficiency
Measured with ActiGraph (accelerometry)
Time frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery
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