Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise Interventions for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy (BENEFIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02999074
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : February 9, 2021
Sponsor:
Collaborator:
University Hospital Heidelberg
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Breast Cancer Other: Resistance exercise Other: Aerobic exercise Other: Usual care during neoadjuvant chemotherapy/Exercise after surgery Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized 3-arm Exercise Intervention Trial for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
Study Start Date : January 2016
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Resistance exercise Other: 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).

Active Comparator: Aerobic exercise Other: 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.

Waitlist control Other: 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.




Primary Outcome Measures :
  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 Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999074


Contacts
Layout table for location contacts
Contact: Martina E Schmidt, Dr. +49 6221 42 2220 m.schmidt@dkfz.de
Contact: Karen Steindorf, Prof. Dr. +49 6221 42 2351 k.steindorf@dkfz.de

Locations
Layout table for location information
Germany
National Center for Tumor Diseases (NCT) Recruiting
Heidelberg, Germany, 69120
Contact: Martina E Schmidt, Dr.    +49 6221 42 2220    m.schmidt@dkfz.de   
Contact: Karen Steindorf, Prof. Dr.    +49 6221 42 2351    k.steindorf@dkfz.de   
Sponsors and Collaborators
German Cancer Research Center
University Hospital Heidelberg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT02999074    
Other Study ID Numbers: BENEFIT
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by German Cancer Research Center:
exercise
resistance training
aerobic training
breast cancer
neoadjuvant chemotherapy
fatigue
quality of life
tumor response
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases