Status:

COMPLETED

Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial

Lead Sponsor:

University of Washington

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Invasive Breast Carcinoma

Eligibility:

FEMALE

18-75 years

Phase:

NA

Brief Summary

This clinical trial studies the feasibility of implementing various adaptive training exercise programs to improve cardiorespiratory fitness in patients after receiving breast cancer treatment. Inform...

Detailed Description

OUTLINE: Patients are randomized to the interventional groups or control group. INTERVENTION GROUPS: Patients are randomized to 1 of 2 interventional arms. ARM I: Patients participate in aerobic exe...

Eligibility Criteria

Inclusion

  • Age 18 - 75 years, inclusive
  • Female gender
  • Prior diagnosis of invasive breast cancer
  • Completion of chemotherapy or receipt of trastuzumab (Herceptin) therapy within the past 6 - 60 months (0.5 - 5 years)
  • Reduced cardiorespiratory functional capacity, defined as below the median estimated CRF for age/sex-matched controls

Exclusion

  • Actively receiving radiation treatment
  • Medical history of heart failure, coronary artery disease or arrhythmia
  • Contraindications to cardiopulmonary exercise testing (CPET)
  • Contraindications to magnetic resonance imaging (MRI) (e.g ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices, non-compatible MRI tissue expanders or breast implants, or other implanted non-compatible MRI devices), weight over 550 lbs, or symptomatic claustrophobia
  • Contraindications to exercise, including a history of surgery with sequelae that restrict ability to exercise safely or comfortably
  • Unwilling to complete intervention procedures or outcome measures

Key Trial Info

Start Date :

January 5 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 10 2022

Estimated Enrollment :

27 Patients enrolled

Trial Details

Trial ID

NCT04667481

Start Date

January 5 2022

End Date

November 10 2022

Last Update

February 12 2024

Active Locations (1)

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1

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109