Exercise Program for Breast Cancer

Overseen By Aaron Roberts, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Hawaii

Disqualifiers: Breast cancer recurrence, Metastatic, Psychiatric, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

165 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators are doing this study to determine if there are body composition changes after a 12-week exercise program in breast cancer patients and determine what factors contribute to sustained physical activity after the 12-week exercise program intervention.

Research Team

Jami A. Fukui

Principal Investigator

University of Hawaii Cancer Research Center

Eligibility Criteria

This trial is for individuals newly diagnosed with breast cancer (within the past 2 years, stages I-III) who can be undergoing various treatments. Participants must be able to perform physical activities like lying flat and standing without aid, and commit to a 12-week exercise program including assessments.

Inclusion Criteria

I can lie flat on my back for up to 10 minutes.

I was diagnosed with breast cancer less than 2 years ago, at stage I-III.

I can stand on my own for at least 2 minutes.

Exclusion Criteria

My breast cancer has come back.

Pregnant patient

My breast cancer has spread to other parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week exercise program with biometric evaluations

12 weeks

Biometric evaluations at baseline and end of 12 weeks

Follow-up

Participants are monitored for sustained physical activity and undergo annual medical review

5 years

Annual visits for medical review

Extension

Participants in Group 1 continue with exercise group or individual classes and are followed for the remainder of the year

Remainder of the year

Treatment Details

Interventions

• Exercise

Trial Overview The study tests the impact of a 12-week exercise regimen on body composition in breast cancer patients. It also aims to identify factors that encourage ongoing physical activity post-intervention.

Participant Groups

Group I: Group 2 - Declines Exercise Program Active Control 1 Intervention

Same biometric and biomarker assessment at as Group 1 (at baseline, after 12 weeks and annually) however they will not participate in the exercise sessions

Group II: Group 1 - Agree to Exercise Program Active Control 1 Intervention

12-week exercise program

Who Is Running the Clinical Trial?

University of Hawaii

Lead Sponsor

Trials

122

Recruited

55,200+

Rehabilitation Hospital of the Pacific

Collaborator

Trials

1

Recruited

170+