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Physical Exercise During Preoperative Chemotherapy for Breast Cancer (Neo-ACT)

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: NCT05184582
Recruitment Status : Not yet recruiting
First Posted : January 11, 2022
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Karolinska Institutet

Brief Summary:

Neoadjuvant chemotherapy (NACT) is increasingly used in breast cancer. The best proof of NACT efficacy is pathological complete response (pCR), i.e. the absence of invasive tumour on post-NACT surgical histopathology. While it is known that physical exercise can help patients to better tolerate and complete often harsh cancer treatments, it is an emerging area of research to understand if and how exercise exerts anti-tumour effects and improves oncological outcomes.

The main aim of the Neo-ACT trial is to examine if a physical exercise intervention during NACT can increase pCR rates in breast cancer. Secondary aims are patient-related outcomes (health-related quality of life, physical activity), physiological outcomes (muscle strength, cardiorespiratory fitness), cancer treatment-related toxicities (cognitive dysfunction, chemotherapy completion rates) and long-term sick leave. Furthermore, the trial will explore how physical exercise affects anti-tumoral mechanisms inherent to therapy or host by hypothesis-generating translational analyses.

712 patients with primary invasive breast cancer will be randomized to either a supervised intervention of high-intensity interval and resistance training during NACT, supported by an exercise app, or to usual care, and followed for two years. Physical activity is meticulously tracked. By offering patients active involvement, the trial contributes strongly to the concept of personalized medicine.


Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Physical training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 712 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization to supervised high-intensity interval training during neoadjuvant chemotherapy or usual information about physical activity.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Exercise During Neoadjuvant Chemotherapy for Breast Cancer as a Means to Increase Pathological Complete Response Rates: the Randomized Neo-ACT Trial
Estimated Study Start Date : August 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard
Routine information on the benefit of physical activity
Experimental: Intervention
High-intensity interval and strength training during neoadjuvant chemotherapy
Behavioral: Physical training
Participants randomized to the exercise group will complete two structured 60-min exercise sessions per week from initiation of NACT to surgery (approx. five months).




Primary Outcome Measures :
  1. Pathological complete response [ Time Frame: 5-6 months ]
    Absence of residual invasive tumor in breast and axilla at surgery


Secondary Outcome Measures :
  1. Global health-related quality of life [ Time Frame: baseline, after 1 and 2 years ]
    assessed by the EORTC QLQ-C30 questionnaire

  2. Breast cancer-related quality of life [ Time Frame: baseline, after 1 and 2 years ]
    assessed by the EORTC QLQ-B23 questionnaire

  3. Self-reported physical activity [ Time Frame: baseline, pre-surgery, 1- and 2-year follow-up ]
    Modified Godin Leisure Time Physical activity questionnaire

  4. Chemotherapy completion rate [ Time Frame: 1 year ]
    proportion of participants receiving the planned number of treatments

  5. Cumulative chemotherapy dosage [ Time Frame: 1 year ]
    total dose of NACT received to account for potential dose reduction

  6. Objective cognitive dysfunction [ Time Frame: baseline and 1 year ]
    online neuropsychological test (Amsterdam Cognition Scan)

  7. Sick leave [ Time Frame: pre-surgery and at 1- and 2-year follow-up ]
    Patient-reported absence from work

  8. Device-measured physical activity level [ Time Frame: baseline and 5-6months (pre surgery) ]
    Fit-bit tracker

  9. Device-measured sleep quality [ Time Frame: baseline and 5-6months (pre surgery) ]
    Fit-bit tracker

  10. Muscle strength [ Time Frame: baseline and 5-6 months ]
    hypothetical 1-RM maximal leg muscle strength test

  11. Handgrip strength [ Time Frame: baseline and 5-6 months ]
    handgrip strength test

  12. Cardiorespiratory fitness [ Time Frame: baseline and 5-6 months (pre-surgery) ]
    Åstrand submaximal cycle test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with primary invasive breast cancer cT1-T3 cN0-2
  • Full tumour biology available before initiation of NACT
  • Oral and written consent
  • Age ≥ 18 years
  • Able to travel to the exercise testing and training premises
  • Anticipates being able to adhere to the exercise program requirements

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Inability to absorb or understand the meaning of the study
  • The presence of musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study
  • Currently performing equal to or more than 150 mins of moderate to high intensity aerobic exercise and 2 sessions per week of moderate intensity resistance exercise
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Responsible Party: Karolinska Institutet
ClinicalTrials.gov Identifier: NCT05184582    
Other Study ID Numbers: Neo-ACT
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases