Exercise Intervention for Dense Breast Tissue

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Oral contraceptives

Disqualifiers: Cardiovascular, respiratory, musculoskeletal, psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how exercise affects certain markers in the breast tissue and blood of women with dense breast tissue. It focuses on premenopausal women who have been less active and have dense breast tissue, as shown on a recent mammogram. Participants will join a supervised exercise program (Exercise Intervention) and receive support to increase their activity levels. Women who exercise less than 90 minutes per week and can physically handle moderate exercise may be suitable for this trial. As an unphased study, this trial provides a unique opportunity to contribute to research that could enhance health recommendations for women with dense breast tissue.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on oral contraceptives, you may not be eligible to participate.

What prior data suggests that this exercise intervention is safe for premenopausal women with dense breast tissue?

Research has shown that exercise is generally safe for women, including those with dense breast tissue. Studies have found that aerobic and resistance exercises can enhance overall fitness and health without causing major harm. Participants in these studies did not report any serious side effects.

Moreover, exercise has been linked to a lower risk of breast cancer recurrence and a reduced risk of death in patients. This indicates that regular physical activity is not only safe but also beneficial for long-term health. While this study focuses on exercise for dense breast tissue, existing evidence shows that similar exercise programs are well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise intervention for dense breast tissue because it offers a non-invasive, lifestyle-based approach to potentially manage this condition. Unlike current options, which often focus on imaging and surveillance, this treatment emphasizes moderate-intensity aerobic exercise as a proactive strategy. This method not only aims to improve breast tissue density but also promotes overall health through increased physical activity and social support, potentially offering benefits beyond traditional medical treatments.

What evidence suggests that exercise intervention is effective for dense breast tissue?

Research has shown that exercise might help reduce the risk of breast cancer in women with dense breast tissue. This trial will evaluate a specific exercise intervention, consisting of a supervised, moderate-intensity aerobic exercise program. Studies have found that exercise can lead to positive changes in blood and breast tissue, which are indicators of disease. Evidence also suggests that physical activity is linked to lower rates of breast cancer recurrence and fewer deaths from it. Aerobic exercise, in particular, has been connected to changes in breast tissue density, which could be beneficial. Overall, exercise appears promising as a way to manage dense breast tissue. ^{1 2 4 6 7}

Who Is on the Research Team?

Jennifer Ligibel, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for premenopausal women under 50 with dense breast tissue who don't exercise much (less than 90 minutes of moderate activity per week). They must be able to read English, have no history of breast cancer, and can walk at least two blocks. Women on oral contraceptives or with certain diseases that limit exercise are not eligible.

Inclusion Criteria

I am a premenopausal woman with regular periods.

I am a premenopausal woman who has had a hysterectomy but still have my ovaries.

I have never had breast cancer before.

Exclusion Criteria

I cannot walk 2 blocks without assistance.

I had breast cancer or DCIS before, but I'm not on hormone therapy and have one breast not treated with radiation.

You have a mental health condition, like severe depression, substance abuse, or severe personality disorder, that would make it hard for you to take part in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a supervised, moderate-intensity aerobic exercise program for 12 weeks

12 weeks

Participants have the option of a third supervised session each week

Follow-up

Participants are monitored for changes in breast tissue and blood markers after the exercise intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention

Trial Overview The study looks at how regular exercise affects markers in the blood and breast tissue related to health. Participants will engage in an exercise intervention designed to see if physical activity can influence factors associated with breast cancer risk.

How Is the Trial Designed?

Group I: Physical activity Experimental Treatment 1 Intervention

* The exercise intervention will consist of a supervised, moderate-intensity aerobic exercise program. * Will receive social/behavioral support * Will receive research staff contact time to encourage them to increase their physical activity level * The participants will be given the option of a third supervised session each week

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 20 breast cancer patients undergoing neoadjuvant chemotherapy, those who participated in moderate-to-high intensity aerobic training showed a significant improvement in cardiopulmonary function, with a 13.3% increase in VO2peak compared to a decrease in the control group.

The aerobic training was found to be safe, with only one adverse event reported during the training sessions, and no significant differences in treatment-related side effects between the groups, indicating that it can be a beneficial adjunct therapy during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. Hornsby, WE., Douglas, PS., West, MJ., et al.[2022]

A 12-week exercise training program with follow-up phone calls significantly increased the number of 'very active' women and overall physical activity levels in the intervention group of 31 women recovering from breast cancer surgery, compared to a control group.

The increased physical activity was associated with improved quality of life, particularly in the 'future healthy function' area, although some symptoms related to treatment side effects did increase, indicating a complex relationship between exercise and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise training and follow-up calls at home on physical activity and quality of life after a mastectomy. Nemli, A., Tekinsoy Kartin, P.[2019]

Resistance training (RT) is safe for breast cancer survivors (BCS) and does not increase the risk of lymphedema, based on an analysis of ten studies published between 2000 and 2016.

RT effectively improves muscle strength in BCS, particularly when using high loads, although changes in body mass composition were minimal, indicating the need for careful manipulation of training variables for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Effects of Resistance Training in Breast Cancer Survivors. Dos Santos, WDN., Gentil, P., de Moraes, RF., et al.[2018]

A systematic review of 50 studies on resistance training for breast cancer patients found that only 66% adhered to the American College of Sports Medicine guidelines, indicating a gap in compliance with established exercise recommendations.

Despite an average adherence rate of 84%, many studies did not specify the exercises used, and only half of the regimens were designed to achieve muscle hypertrophy, suggesting a need for better-defined exercise protocols in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantity of Resistance Exercise for Breast Cancer Patients: Does the Dose Match the Objective? Rosenberg, J., Hyde, PN., Yancy, WS., et al.[2023]

A 3-week rehabilitation program using high-intensity interval training (HIIT) was safe for female breast cancer survivors, with no reported adverse events, and effectively reduced body fat without affecting overall body mass.

Both HIIT and low-to-moderate intensity exercise (LMIE) improved quality of life and reduced cancer-related fatigue, but HIIT was more time-efficient, making it a practical option for enhancing health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 3-week multimodal intervention involving high-intensity interval training in female cancer survivors: a randomized controlled trial. Schmitt, J., Lindner, N., Reuss-Borst, M., et al.[2021]

In a study involving breast cancer survivors at risk for lymphedema, weightlifting showed a higher rate of musculoskeletal injuries compared to standard care, with injury rates of 2.3 per 1,000 bouts for the weightlifting group.

Despite the efficacy of weightlifting as a rehabilitative exercise, 20.9% of participants required medical attention that led to modifications in their exercise regimen, highlighting the need for well-trained health and fitness professionals to safely implement such programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of weightlifting among women with or at risk for breast cancer-related lymphedema: musculoskeletal injuries and health care use in a weightlifting rehabilitation trial. Brown, JC., Troxel, AB., Schmitz, KH.[2021]

The ABRACE Study will evaluate the effects of different volumes of resistance training combined with aerobic exercise on physical and psychological outcomes in 84 breast cancer patients undergoing chemotherapy, aiming to clarify optimal exercise prescriptions during treatment.

The study hypothesizes that both resistance training groups (single and multiple sets) will show superior improvements in neuromuscular function and quality of life compared to a control group, potentially establishing exercise as a key management strategy for treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial. Henkin, JS., Rosa, DD., Morelle, AM., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06322888

Resistance and Aerobic Exercise for Prevention in Women ... The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer in women with dense breast tissue by studying ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-02875

A Resistance and Aerobic Training Exercise Intervention ... This clinical trial evaluates the effects of whether an exercise program might impact blood and breast tissue markers (detection of the presence of a disease)

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9021138/

Impact of exercise interventions on physical fitness in ... Our results recommend resistance training and combined aerobic-resistance training interventions for positive changes to the evaluated outcomes.

4. 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2945907/

Mammographic Density Change with One Year of Aerobic ... This trial was designed to examine aerobic exercise in postmenopausal women in relation to putative biological intermediates of the inverse association between ...

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. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024023491

Effects of aerobic combined with resistance exercise on ... Aerobic combined with resistance exercise significantly improved cardiorespiratory fitness levels and cardiometabolic health in breast cancer survivors.