Can exercise slash heart and diabetes risks in latina breast cancer survivors?
NCT ID NCT04717050
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This trial investigates whether a structured exercise program can improve fitness and lower risk factors for heart disease, stroke, and type 2 diabetes in Latina women who have had breast cancer. Participants are randomly assigned to either an 8-month progressive exercise program or a 12-month stretching program for comparison. The goal is to see if exercise helps control metabolic issues linked to obesity in this specific group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Progressive combine training (PCT) - an 8-month exercise program
- What this could lead to
- If successful, this could show that a structured exercise program reduces metabolic risks like heart disease and diabetes in Latina breast cancer survivors, improving long-term health outcomes.
- What could go wrong
- This is a small, early-stage trial with only 64 participants, so results may not apply broadly. The exercise program requires commitment, and adherence may vary, affecting outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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64 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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