JOURNAL ONKOLOGIE – STUDIE
BENEFIT Exercise Interventions for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
Rekrutierend
NCT-Nummer:
NCT02999074
Studienbeginn:
Januar 2016
Letztes Update:
09.02.2021
Wirkstoff:
-
Indikation (Clinical Trials):
Breast Neoplasms
Geschlecht:
Frauen
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
German Cancer Research Center
Collaborator:
University Hospital Heidelberg
Kontakt
Kontakt:
Phone: +49 6221 42 2220
E-Mail: m.schmidt@dkfz.de» Kontaktdaten anzeigen
Kontakt:
Phone: +49 6221 42 2351
E-Mail: k.steindorf@dkfz.de» Kontaktdaten anzeigen
Studienlocations (1 von 1)
National Center for Tumor Diseases (NCT)
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Martina E Schmidt, Dr.
Phone: +49 6221 42 2220
E-Mail: m.schmidt@dkfz.de
Karen Steindorf, Prof. Dr.
Phone: +49 6221 42 2351
E-Mail: k.steindorf@dkfz.de» Ansprechpartner anzeigen
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Martina E Schmidt, Dr.
Phone: +49 6221 42 2220
E-Mail: m.schmidt@dkfz.de
Karen Steindorf, Prof. Dr.
Phone: +49 6221 42 2351
E-Mail: k.steindorf@dkfz.de» Ansprechpartner anzeigen
Studien-Informationen
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.
Ein-/Ausschlusskriterien
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)
Studien-Rationale
Primary outcome:1. Tumor size (Time Frame - 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:
1. CPS-EG score (Time Frame - 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.
2. pCR (Time Frame - 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.
3. Fatigue Assessment Questionnaire (FAQ) (Time Frame - 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
4. EORTC QLQ-C30 / BR23 (Time Frame - 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.
5. Patient Health Questionnaire for Depression and Anxiety (PHQ-4) (Time Frame - 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.
6. Pittsburgh Sleep Quality Index (PSQI) (Time Frame - 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.
7. Spiroergometry (VO2max) (Time Frame - at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery)
8. Isometric and isokinetic muscle strength measured by ISOMED 2000 (Time Frame - at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery)
9. Body mass index (Time Frame - at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery)
10. 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))
11. Cognitive function - HVLT-R (Time Frame - at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery):
Hopkins Verbal Learning Test - Revised (HVLT-R)
12. Cognitive function - TMT (Time Frame - at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery):
Trail Making Test
13. Cognitive function - COWA (Time Frame - at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery):
Controlled Oral Word Association
14. Sleep quality (Time Frame - at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery):
Measured with ActiGraph (accelerometry)
15. Sleep efficiency (Time Frame - at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery):
Measured with ActiGraph (accelerometry)
Studien-Arme
- Active Comparator: Resistance exercise
- Active Comparator: Aerobic exercise
- Other: Waitlist control
Geprüfte Regime
- 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.
Quelle: ClinicalTrials.gov
