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Physical Activity During Chemotherapy for Breast Cancer

N/A

Recruiting

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

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compare the change in p16 from baseline to end of chemotherapy

Secondary outcome measures

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 outcome measures

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

Measure association of p16 with body composition

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 / 2Eligibility criteria met

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Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,233 Total Patients Enrolled

51 Trials studying Breast Cancer

27,886 Patients Enrolled for Breast Cancer

Breast Cancer Research FoundationOTHER

69 Previous Clinical Trials

137,667 Total Patients Enrolled

41 Trials studying Breast Cancer

130,377 Patients Enrolled for Breast Cancer

Hyman B. Muss, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

2 Previous Clinical Trials

5,820 Total Patients Enrolled

2 Trials studying Breast Cancer

5,820 Patients Enrolled for Breast Cancer

Media Library

Engagement in Physical Activity Clinical Trial Eligibility Overview. Trial Name: NCT03761706 — N/A

Breast Cancer Research Study Groups: Intervention Cohort

Breast Cancer Clinical Trial 2023: Engagement in Physical Activity Highlights & Side Effects. Trial Name: NCT03761706 — N/A

Engagement in Physical Activity 2023 Treatment Timeline for Medical Study. Trial Name: NCT03761706 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility requirements for participating in this research?

"This clinical trial is recruiting 100 individuals aged 21 to 64 who have been recently diagnosed with breast cancer. For eligibility, they must be able and willing to comply with all study requirements, possess the capacity for moderate-intensity physical activity as determined by themselves and their physician, understand English fluently enough to provide informed consent, agree with NCCN guidelines regarding appropriate adjuvant or neo-adjuvant chemotherapy if applicable (with consideration for anti-HER2 therapy), and hold a histologically confirmed diagnosis of Stage I, II or III breast cancer."

Answered by AI

How many people can feasibly join this clinical investigation?

"Correct. According to the information posted on clinicaltrials.gov, this medical experiment is still seeking participants and was first launched on February 28th 2018. An additional 100 individuals will be recruited from a single site before study completion."

Answered by AI

Is this experiment currently available for those seeking treatment?

"True, according to clinicaltrials.gov this medical trial is currently enrolling patients. It was first posted on February 28th 2018 and the most recent update was November 28th 2022. The study requires 100 participants across one location."

Answered by AI

Is this research project accepting applicants who are in the geriatric age range?

"This clinical trial has proscribed the age of participation to individuals between 21 and 64 years old. For those below 18, there are 74 studies available; for seniors above 65 , 2507 trials can be found."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging

2018. "Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03761706.

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