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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether exercising during chemotherapy can help manage changes in p16 levels, a protein related to cell aging, in patients with Stage I-III breast cancer. Participants will engage in home-based aerobic and strength exercises, track their activity with a FitBit, and complete various assessments. This trial suits women who can engage in moderate physical activity and are about to start chemotherapy for breast cancer. As an unphased trial, it offers a unique opportunity to contribute to research that could improve quality of life during chemotherapy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinators.

What prior data suggests that this physical activity intervention is safe for breast cancer patients undergoing chemotherapy?

Research has shown that aerobic and strength exercises at home are generally safe for breast cancer patients undergoing chemotherapy. Some studies have identified mild side effects, such as low red blood cell count, dizziness, and shortness of breath. Other potential issues include shoulder pain and swelling in the armpit area. However, an online home exercise program demonstrated that exercising at home during a restrictive period was safe and beneficial for breast cancer patients. While minor side effects may occur, the overall safety of these exercise programs remains positive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about home-based aerobic and strength exercises during chemotherapy for breast cancer because they offer a unique, non-pharmacological approach to enhancing patient well-being. Unlike traditional treatments, which primarily focus on medication and surgery, this approach empowers patients to actively participate in their health management through physical activity, potentially improving quality of life and treatment outcomes. The use of a FitBit to track activity levels provides real-time data and personalized feedback, encouraging consistent engagement and offering insights into the impact of exercise on recovery during and after chemotherapy.

What evidence suggests that physical activity during chemotherapy might be effective for breast cancer?

Research has shown that aerobic and strength exercises at home can benefit breast cancer patients undergoing chemotherapy. Studies have found that these exercises can enhance quality of life and help patients remain active. In this trial, participants will perform home-based aerobic and strength exercises while receiving chemotherapy. Exercise is linked to improvements in overall health and physical abilities. Staying active during treatment may help manage some challenges faced during chemotherapy. ^{4 5 6 7 8}

Who Is on the Research Team?

Hyman B. Muss, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10405487/

Effectiveness of home-based exercise in breast cancer ... This home-based exercise regime effectively increased quality of life and physical activity levels.

2. nature.com nature.com/articles/s41598-025-11660-0

Implementing exercise and self-management for women ... Exercise levels decrease even further during treatment, with over 77% of those receiving chemotherapy not engaging in any form of exercise. The ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2095254625000432

Effects of aerobic or resistance exercise during ... A case-control study involving 243 breast cancer patients receiving NACT found that exercise was significantly associated with higher odds for chemotherapy ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06429189

an Online Home-based Combined Exercise Intervention for ... This study will be a 2-arm pragmatic randomized controlled trial, Home-Combo, which will target Portuguese women with a breast cancer diagnosis undergoing ...

5. cardiooncologyjournal.biomedcentral.com cardiooncologyjournal.biomedcentral.com/articles/10.1186/s40959-024-00235-z

Effectiveness of exercise modalities on breast cancer patient ... Overall exercise significantly improves the HRQOL, CRF and physical function in patients with BC. HRQOL was improved with all exercise types.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12283810/

Home-based exercise interventions' impact on breast ... Adverse effects related to exercise were reported in some studies, such as anemia, dizziness, and dyspnoea [54], shoulder pain and swelling of the axillary ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9039602/

Effects of an online home-based exercise intervention on ... This feasibility study suggests that an online home-based exercise intervention performed during a confinement period is safe and beneficial for breast cancer ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1462388924000528

Feasibility of a novel exercise program for patients with ... This study explored the feasibility of an exercise program in which women with breast cancer may be allowed to choose among three exercise delivery modalities.