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Physical Activity During Chemotherapy for Breast Cancer

N/A

Waitlist Available

Led By Hyman B. Muss, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)

21 to 64 years of age, female

Must not have

Unable to walk or engage in moderate-intensity physical activity.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, during chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks) , and 12-months post-baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether being physically active during chemotherapy can help moderate increases in p16 levels. 100 patients with breast cancer will be recruited and monitored throughout their chemotherapy treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention includes physical activity rather than medication or medical procedures, side effects may include typical exercise-related issues such as muscle soreness or fatigue but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am a woman aged between 21 and 64.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot walk or do moderate exercises.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, during chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post baseline, 12-months post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, during chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post baseline, 12-months post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, during chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post baseline, 12-months post-baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compare the change in p16 from baseline to end of chemotherapy

Secondary study objectives

Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the CTCAE.

Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the FACT/GOG-NTX

Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the PRO-CTCAE.

+18 more

Other study objectives

Mean change in p16 between baseline to end of chemo, compared to previous studies

Measure association of p16 with body composition

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention CohortExperimental Treatment2 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.

0 / 3Eligibility criteria met