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

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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

Tracking Information
First Submitted Date  ICMJE May 6, 2016
First Posted Date  ICMJE December 21, 2016
Last Update Posted Date February 9, 2021
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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 [ Time Frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery ]
    Hopkins Verbal Learning Test - Revised (HVLT-R)
  • Cognitive function - TMT [ Time Frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery ]
    Trail Making Test
  • Cognitive function - COWA [ Time Frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery ]
    Controlled Oral Word Association
  • Sleep quality [ Time Frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery ]
    Measured with ActiGraph (accelerometry)
  • Sleep efficiency [ Time Frame: at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery ]
    Measured with ActiGraph (accelerometry)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • 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.
  • Fatigue Assessment Questionnaire (FAQ) [ Time Frame: at baseline, week 9 and 19; 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 [ Time Frame: at baseline, week 9 and 19; months 6 and 12 after breast surgery ]
    Validated 30-item self-assessment questionnaire to assess quality of life aspects.
  • Patient Health Questionnaire for Depression and Anxiety (PHQ-4) [ Time Frame: at baseline, week 9 and 19; months 6 and 12 after breast surgery ]
    A validated 4-item screener for depression and anxiety.
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: at baseline, week 9 and 19; months 6 and 12 after breast surgery ]
    Validated questionnaire to assess sleep quality and sleep problems.
  • Spiroergometry (VO2max) [ Time Frame: at baseline, week 19, month 6 after breast surgery ]
  • Isometric and isokinetic muscle strength measured by ISOMED 2000 [ Time Frame: at baseline, week 19, month 6 after breast surgery ]
  • Body mass index [ Time Frame: at baseline, week 19, month 6 after breast surgery ]
  • Self-developped 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) ]
  • Tumor size [ Time Frame: at diagnosis (measured by sonography or mammography) and at breast surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Interventions for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
Official Title  ICMJE A Randomized 3-arm Exercise Intervention Trial for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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).
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Resistance exercise
    Intervention: Other: Resistance exercise
  • Active Comparator: Aerobic exercise
    Intervention: Other: Aerobic exercise
  • Waitlist control
    Intervention: Other: Usual care during neoadjuvant chemotherapy/Exercise after surgery
Publications * Kreutz C, Müller J, Schmidt ME, Steindorf K. Comparison of subjectively and objectively assessed sleep problems in breast cancer patients starting neoadjuvant chemotherapy. Support Care Cancer. 2021 Feb;29(2):1015-1023. doi: 10.1007/s00520-020-05580-0. Epub 2020 Jun 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2018)
240
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2016)
342
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02999074
Other Study ID Numbers  ICMJE BENEFIT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party German Cancer Research Center
Study Sponsor  ICMJE German Cancer Research Center
Collaborators  ICMJE University Hospital Heidelberg
Investigators  ICMJE Not Provided
PRS Account German Cancer Research Center
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP