Can exercise slash heart and diabetes risks in latina breast cancer survivors?

NCT ID NCT04717050

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

64 people

The number who actually took part.

Started

Sep 2021

Finished

Jun 2025

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

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