Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02999074

Exercise Interventions for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Fatigue Motor Activity Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Center for Tumor Diseases (NCT)

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Resistance Exercise

Other

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

Other

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

Other

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Collaborators

  • University Hospital Heidelberg

Registry information

Official study title

A Randomized 3-arm Exercise Intervention Trial for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy

Acronym: BENEFIT

Important dates

Study start
2016
Primary completion
2023
Study completion
2025
First posted
Dec 21, 2016
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.