60 Participants Needed

Exercise Intervention for Dense Breast Tissue

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

Trial Summary

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 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.12345

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.678910

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.511121314

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.

Research Team

Jennifer A. Ligibel, MD - Dana-Farber ...

Jennifer Ligibel, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.
See 6 more

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.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Physical activityExperimental Treatment1 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

Find a Clinic Near You

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+

Findings from Research

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

References

Exercise after breast cancer treatment: current perspectives. [2020]
Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. [2022]
Full-body exercise training improves fitness and quality of life in survivors of breast cancer. [2016]
Effects of exercise training and follow-up calls at home on physical activity and quality of life after a mastectomy. [2019]
Quantity of Resistance Exercise for Breast Cancer Patients: Does the Dose Match the Objective? [2023]
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]
Chronic Effects of Resistance Training in Breast Cancer Survivors. [2018]
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]
Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial. [2023]
10.United Statespubmed.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 Statespubmed.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 Statespubmed.ncbi.nlm.nih.gov
Once a Week Resistance Training Improves Muscular Strength in Breast Cancer Survivors: A Randomized Controlled Trial. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Muscle strength, body composition, and physical activity in women receiving chemotherapy for breast cancer. [2006]
14.United Statespubmed.ncbi.nlm.nih.gov
A 3-week multimodal intervention involving high-intensity interval training in female cancer survivors: a randomized controlled trial. [2021]
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