NCT04724499

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

Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (The CLARITY Trial)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to determine whether a 16-week high intensity interval training (HIIT) exercise program will improve brain health among women undergoing chemotherapy and also improve cardiovascular (heart) function. The names of the study interventions involved in this study are/is: * High-Intensity Interval Training (HIIT)

Detailed description

This research study is a randomized controlled pilot trial that will compare an exercise group to a control group on brain health, cardiac fitness and overall quality of life in breast cancer patients starting chemotherapy either before (pre-operative or neoadjuvant) or after surgery (post-operative or adjuvant) This research study is a Pilot Study, which is the first-time investigators are examining this intervention in this setting. The study is trying to determine whether participating in a specific exercise program can improve brain and heart function, as there is some evidence that there can be cognitive changes after chemotherapy among some patients with breast cancer. This study intends to evaluate whether HIIT can improve cognitive function as well as cardio-respiratory fitness, among patients undergoing chemotherapy for breast cancer. Participants will be randomly assigned to one of two groups: * Group A: High Intensity Interval Training (HIIT) for 16 weeks * Group B: Attention Control for 16 weeks home-based stretching; the HIIT intervention will be available after the study ends The research study procedures include screening for eligibility and study treatment including extensive evaluations of your fitness and brain health, including MRI, blood tests, bone scans, fitness and strength assessments, and surveys at study entry and follow up visits. Participants will receive study treatment for 4 months and will be followed for 4 months. The total time for participation in this study will be about 8 months. It is expected that about 30 people will take part in this research study. The American Institute for Cancer Research is supporting this research by providing funding for the study.

Conditions

• Breast Cancer
• Chemotherapy Effect
• Exercise Therapy
• Cognitive Change

Interventions

Type	Name	Description
BEHAVIORAL	High-Intensity Intervals Training	16 week exercise program with stationary bike.
OTHER	Attention Control	16 week stretching program.

Timeline

• Start date: 2021-07-14
• Primary completion: 2026-08-01
• Completion: 2027-04-01
• First posted: 2021-01-26
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States