Breast Cancer Clinical Trial
— BENEFITOfficial title:
A Randomized 3-arm Exercise Intervention Trial for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
Verified date | February 2023 |
Source | German Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 183 |
Est. completion date | July 2024 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Germany | National Center for Tumor Diseases (NCT) | Heidelberg |
Lead Sponsor | Collaborator |
---|---|
German Cancer Research Center | University Hospital Heidelberg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | change from baseline (before start of neoadjuvant chemotherapy) to breast surgery | |
Secondary | 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. | at breast surgery | |
Secondary | 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. | at breast surgery | |
Secondary | Fatigue Assessment Questionnaire (FAQ) | Validated 20-item multidimensional self-assessment questionnaire to assess the physical, affective, and cognitive dimension of cancer-related fatigue | at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery | |
Secondary | EORTC QLQ-C30 / BR23 | Validated 30-item self-assessment questionnaire to assess quality of life aspects. | at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery | |
Secondary | Patient Health Questionnaire for Depression and Anxiety (PHQ-4) | A validated 4-item screener for depression and anxiety. | at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) | Validated questionnaire to assess sleep quality and sleep problems. | at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery | |
Secondary | Spiroergometry (VO2max) | at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery | ||
Secondary | Isometric and isokinetic muscle strength measured by ISOMED 2000 | at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery | ||
Secondary | Body mass index | at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery | ||
Secondary | 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) | ||
Secondary | Cognitive function - HVLT-R | Hopkins Verbal Learning Test - Revised (HVLT-R) | at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery | |
Secondary | Cognitive function - TMT | Trail Making Test | at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery | |
Secondary | Cognitive function - COWA | Controlled Oral Word Association | at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery | |
Secondary | Sleep quality | Measured with ActiGraph (accelerometry) | at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery | |
Secondary | Sleep efficiency | Measured with ActiGraph (accelerometry) | at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |