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

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is studying how regular exercise affects breast tissue and blood markers in premenopausal women with dense breast tissue. These women are at higher risk for breast cancer, and exercise might help by slowing cancer cell growth and strengthening the immune system. The study aims to understand these potential benefits better.

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.

Is exercise intervention safe for humans?

Exercise interventions, including aerobic and resistance training, have been shown to be generally safe for humans, including those with breast cancer or at risk for breast cancer. Studies report no increased risk of lymphedema (swelling due to lymph fluid) and low rates of musculoskeletal injuries. ^{1 2 3 4 5}

How does the exercise intervention treatment for dense breast tissue differ from other treatments?

The exercise intervention for dense breast tissue is unique because it focuses on physical activity, specifically aerobic and resistance training, to potentially influence breast density, a known risk factor for breast cancer. Unlike traditional medical treatments, this approach leverages the benefits of exercise, which has been shown to improve muscle strength and body composition in breast cancer survivors, offering a non-invasive and lifestyle-based option. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Exercise Intervention for Dense Breast Tissue?

Research shows that exercise, including aerobic and resistance training, can improve physical fitness, quality of life, and reduce negative side effects in breast cancer survivors. These benefits suggest that similar exercise interventions may be effective for managing dense breast tissue. ^{9 11 12 13 14}

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.

I do not have heart, lung, or joint problems that stop me from doing moderate exercise.

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]

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]

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]

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]

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]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Exercise after breast cancer treatment: current perspectives. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Full-body exercise training improves fitness and quality of life in survivors of breast cancer. [2016]

4. Japan 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Quantity of Resistance Exercise for Breast Cancer Patients: Does the Dose Match the Objective? [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The Dose-Response Effects of Aerobic Exercise on Body Composition and Breast Tissue among Women at High Risk for Breast Cancer: A Randomized Trial. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Chronic Effects of Resistance Training in Breast Cancer Survivors. [2018]

8. England 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. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of Exercise Therapy Dosing Schedule on Impaired Cardiorespiratory Fitness in Patients With Primary Breast Cancer: A Randomized Controlled Trial. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Physical activity in relation to mammographic density in the dutch prospect-European prospective investigation into cancer and nutrition cohort. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Once a Week Resistance Training Improves Muscular Strength in Breast Cancer Survivors: A Randomized Controlled Trial. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Muscle strength, body composition, and physical activity in women receiving chemotherapy for breast cancer. [2006]

14. United States pubmed.ncbi.nlm.nih.gov

A 3-week multimodal intervention involving high-intensity interval training in female cancer survivors: a randomized controlled trial. [2021]