Physical Activity During Chemotherapy for Breast Cancer

Overseen By Erin O Kelly

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Significant medical conditions, unable to walk

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 6

132 Participants Needed

Trial Summary

What is the purpose of this trial?

Purpose: To determine if engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. Participants: 200 patients age 21 or older with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy. Procedures: The study entails screening, recruiting and consenting 200 eligible breast cancer patients who are about to begin adjuvant or neoadjuvant chemotherapy and agree to participate in a physical activity intervention, maintain a printed daily exercise log, wear a FitBit, complete questionnaires and assessments, and provide blood samples at various time points.

Research Team

Hyman B. Muss, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

This trial is for women aged 21-64 with Stage I-III breast cancer, about to start chemotherapy. They must be able to walk, do moderate exercise, and have their doctor's approval to participate in physical activities. Participants need to speak English and provide written consent.

Inclusion Criteria

I have signed the consent form approved by the ethics committee.

I am starting chemotherapy that follows NCCN guidelines, possibly with anti-HER-2 therapy.

My most recent breast cancer diagnosis is at Stage I, II, or III.

Exclusion Criteria

I cannot walk or do moderate exercises.

My doctor thinks my health conditions prevent me from doing walking or strength exercises.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy and Exercise Intervention

Participants undergo adjuvant or neoadjuvant chemotherapy while engaging in a home-based aerobic and strength exercise program. They maintain an exercise log, wear a FitBit, and provide blood samples.

12-30 weeks

Regularly scheduled chemotherapy clinic visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 and 12 months post-baseline.

12 months

Assessments at 6 and 12 months post-baseline

Treatment Details

Interventions

• Home-based Aerobic and Strength Exercises

Trial Overview The study tests if regular aerobic and strength exercises during chemotherapy can affect aging biomarkers in early breast cancer patients. It involves maintaining an exercise log, wearing a FitBit, completing questionnaires, providing blood samples, and following a specific workout regimen.

Participant Groups

Group I: Intervention Cohort Experimental Treatment 2 Interventions

This is a one-arm intervention study that includes assessments and questionnaires at several time points as early stage breast cancer patients undergo chemotherapy and at 6 months post-chemotherapy. Study participants will be asked to wear a FitBit provided by the research team and agree to FitBit data downloads during regularly scheduled chemotherapy clinic visits to evaluate engagement in physical activity. Study participants will complete questionnaires, an exercise log, and submit blood samples as multiple time points.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+