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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how a 12-week exercise program might change body composition in breast cancer patients and identifies factors that help maintain physical activity afterward. Participants will either join the exercise program or not, with both groups undergoing health assessments over time. Those newly diagnosed with breast cancer (within the last 2 years) and able to participate in regular exercise sessions are a good fit. The study aims to improve understanding of how exercise can benefit those undergoing breast cancer treatment. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could enhance exercise recommendations for breast cancer patients.

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 seems you can continue your current treatments, like surgery, chemotherapy, radiation, or endocrine therapy, while participating.

What prior data suggests that this exercise program is safe for breast cancer patients?

Research shows that exercise is generally safe and beneficial for breast cancer patients. Studies have found that regular physical activity may lower the risk of cancer recurrence and reduce the chance of dying from breast cancer over time.

One study found that a high-intensity exercise program, including strength training, significantly lowered the risk of death over eight years. Another study suggested that exercise might improve the quality of life for women who have survived breast cancer.

Overall, evidence suggests that exercise is well-tolerated and can be a safe option for many breast cancer patients seeking to improve their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring exercise as a treatment for breast cancer because it offers a holistic, non-invasive approach that complements traditional therapies like surgery, chemotherapy, and radiation. Unlike these standard treatments, which can have significant side effects, exercise may help improve overall physical fitness, boost mood, and enhance quality of life without adding additional medical interventions. This trial aims to uncover how regular physical activity might influence biometric and biomarker outcomes in breast cancer patients, potentially offering a natural way to support recovery and long-term health.

What evidence suggests that this exercise program is effective for breast cancer patients?

This trial will compare outcomes for breast cancer patients who participate in an exercise program with those who do not. Research has shown that exercise offers many benefits for breast cancer patients. Studies indicate that physical activity can lower the risk of cancer recurrence and reduce death rates. Exercise also enhances heart and lung health, strengthens muscles, and boosts the immune system. Resistance exercises, in particular, are especially helpful for breast cancer patients in building muscle. Overall, staying active after a cancer diagnosis is linked to better survival rates and health outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Jami A. Fukui

Principal Investigator

University of Hawaii Cancer Research Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. biosignaling.biomedcentral.com biosignaling.biomedcentral.com/articles/10.1186/s12964-024-01634-6

Outcomes of physical exercises on initiation, progression, and ... Evidence has suggested that participation in physical activity is correlated with a decrease in reappearance and fatality rates of breast cancer patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4189463/

The Effects of Physical Activity on Breast Cancer Survivors ... The major health outcomes were the increased cardiorespiratory functions, muscular strength, and immune cell components. In particular, aerobic training was ...

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

Feasibility of a novel exercise program for patients with ... Observational researches suggest that postdiagnosis physical activity is associated with a reduction of 26%–45% of breast cancer-specific and 27%–49% of all- ...

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35043

What are the most effective exercise, physical activity and ... Resistance exercise was the most effective intervention to increase lean mass (0.7 kg; 95% CI, 0.5–1.0 kg) in breast cancer patients. Conclusion.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5001940/

Exploration of Exercise Outcome Expectations among Breast ... Overall, findings revealed that breast cancer survivors have low levels of agreement that exercise may mitigate late and long-term cancer and treatment effects.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11075339/

Outcomes of physical exercises on initiation, progression, ... Evidence has suggested that participation in physical activity is correlated with a decrease in reappearance and fatality rates of breast cancer patients.

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

Implementing exercise and self-management for women ... Research suggests that exercise may also play a role in reducing the risk of cancer recurrence. According to leading national and international ...

8. oncologynewscentral.com oncologynewscentral.com/article/survival-benefit-in-breast-cancer-patients-who-exercise

Survival Benefit in Breast Cancer Patients Who Exercise A supervised high-intensity regimen with a resistance training component significantly reduced the risk for death at 8 years of follow-up.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0748798325007152

Effect of physical exercise on the quality of life of women ... Women surviving breast cancer (WSBC) may experience reduced quality of life (QoL) due to disease-associated manifestations and undergone treatment.

10. cancer.gov cancer.gov/news-events/cancer-currents-blog/2020/breast-cancer-survival-exercise

Exercise and Survival for Women with Breast Cancer - NCI Women who engaged in regular physical activity before their cancer diagnosis and after treatment were less likely to have their cancer come back ...