Breast Cancer Clinical Trial

Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity

Summary

This study is about testing whether exercise will improve fitness and lessen risk factors related to heart disease, diabetes, and obesity in Latina breast cancer survivors.

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Full Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The purpose of this research is to determine whether a 16-week exercise program will improve fitness and lessen risk factors related to coronary artery disease, stroke, and type 2 diabetes in patients who have breast cancer and is sustainable for a Latina population to incorporate into their lifestyle following completion of the 16-week intervention.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

Participants in this study will be randomly assigned into one of the study groups: Progressive Combine Training (PCT) or Attention Control.

Progressive combined training (PCT) will be performed in 2 phases:

supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom.
unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home with weekly check-ins with trainer.
Attention Control Group: 51 weeks home-based stretching

All participants will undergo seven blood draws and participate in nine testing visits.

Participation is expected to last 12 months for all participants.

It is expected that about 160 people will take part in this research study.

The American Cancer Society is supporting this research study by providing funding for the research study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Women newly diagnosed (Stage I-III) breast cancer.
Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
Are centrally obese with the following criteria[84] (determined by study team at eligibility screening): BMI >30 kg/m2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat >30% (estimated by bioelectrical impedance), and waist circumference >35 in.
Have undergone a lumpectomy or mastectomy.
Have received and completed neoadjuvant or adjuvant chemotherapy and/or radiation therapy within the past 12 months.
Speak English or Spanish
Self-identify as Latina
Is in breast cancer remission with no detectable disease present
Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
Free from history of chronic disease including uncontrolled diabetes, hypertension or thyroid disease
Have not experienced a weight reduction ≥10% within the past 6 months
Currently participate in less than 60 minutes of structured exercise/week
No planned reconstructive surgery with flap repair during trial and follow-up period
May use adjuvant endocrine therapy if use will be continued for duration of study intervention
Does not smoke (no smoking during previous 12 months)
Willing to travel to Dana-Farber Cancer Institute for necessary data collection
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease; women using Metformin to manage diabetes will be excluded from the trial
Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
Patients with other active malignancies are ineligible for this study.
Patients with metastatic disease
Is not centrally obese as defined above
Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis
History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
Participates in more than 60 minutes of structured exercise/week
Is planning reconstructive surgery with flap repair during trial and follow-up period
Currently smokes
Is unable to travel to Dana-Farber Cancer Institute and/or exercise facility for necessary data collection
Weight reduction ≥ 10% within past 6 months
Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Study is for people with:

Breast Cancer

Estimated Enrollment:

160

Study ID:

NCT04717050

Recruitment Status:

Recruiting

Sponsor:

Dana-Farber Cancer Institute

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There is 1 Location for this study

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Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Christina Dieli-Conwright, PhD, MPH
Contact
617-582-8321
[email protected]
Mary Norris, MS
Contact
857-215-0195
[email protected]
Christina Dieli-Conwright, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

160

Study ID:

NCT04717050

Recruitment Status:

Recruiting

Sponsor:


Dana-Farber Cancer Institute

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