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Search / Trial NCT04724499

Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy

Launched by DANA-FARBER CANCER INSTITUTE · Jan 22, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Breast Cancer Chemotherapy Effect Exercise Therapy Cognitive Change

ClinConnect Summary

This clinical trial is studying whether a 16-week program of high-intensity interval training (HIIT) can help improve brain health and heart function in women undergoing chemotherapy for breast cancer. The researchers want to see if regular exercise can make a positive difference during this challenging time.

To participate, women must be 18 years or older and have a new diagnosis of breast cancer (stages I-III) while planning to receive chemotherapy. They should have a doctor's approval to exercise and currently do less than one hour of structured exercise each week. Participants will need to visit the research center, Dana-Farber Cancer Institute (DFCI), several times for assessments and training sessions. Being open to exercise and willing to commit to the study are key, but women who are pregnant or have certain health conditions cannot join. This trial offers a chance to explore how exercise might support both mental and physical health during cancer treatment.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Written informed consent prior to any study-related procedures
  • Women newly diagnosed (Stage I-III) breast cancer.
  • Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
  • The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
  • Will receive (neo)adjuvant chemotherapy
  • Speak English
  • Able to provide physician clearance to participate in the exercise program
  • Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
  • Have not experienced a weight reduction ≥10% within the past 6 months
  • Currently participate in less than 60 minutes of structured exercise/week
  • Does not smoke (no smoking during previous 12 months)
  • Willing to travel to DFCI for assessments (54 visits total for those who elect the exercise group with on campus training session, 6 visits for those that elect the exercise at home option, 6 visits for those assigned to the control group)
  • Ability to understand and the willingness to sign a written informed consent document.
  • Exclusion Criteria:
  • Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease
  • Patients with other active malignancies are ineligible for this study.
  • Patients with metastatic disease
  • Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
  • Participates in more than 60 minutes of structured exercise/week
  • Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise
  • Have a pacemaker or any implantable device that are not MRI safe; the BWH/DFCI Standard MRI screening form
  • Is unable to travel to DFCI
  • Patients who are pregnant
  • Patients with claustrophobia
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

About Dana Farber Cancer Institute

The Dana-Farber Cancer Institute is a premier cancer research and treatment institution located in Boston, Massachusetts. Renowned for its commitment to advancing cancer care through innovative research, the institute integrates cutting-edge clinical trials with a multidisciplinary approach to patient care. With a focus on translating scientific discoveries into effective therapies, Dana-Farber collaborates with a network of leading researchers and healthcare professionals to improve outcomes for patients with cancer. The institute’s dedication to education, advocacy, and community engagement further underscores its mission to eradicate cancer and enhance the quality of life for those affected by the disease.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Christina Dieli-Conwright, MD

Principal Investigator

Dana-Farber Cancer Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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