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Hidden fat in slim women: could exercise and diet cut breast cancer risk?

NCT ID NCT04267796

Prevention Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study tests whether a lifestyle program combining aerobic exercise, strength training, and dietary coaching can reduce breast cancer risk in normal-weight postmenopausal women. The goal is to lower body fat and inflammation, which are linked to higher cancer risk even in women with a healthy BMI. The trial will enroll 40 women to see if the program is feasible and if participants stick with it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lifestyle intervention (aerobic exercise, resistance training, and dietary recommendations)
What this could lead to
If successful, this could show that a simple diet and exercise program helps lower breast cancer risk in normal-weight women with hidden excess body fat.
What could go wrong
This is a small, early feasibility study with only 40 participants, so results may not apply widely. It focuses on adherence and eligibility, not directly on cancer reduction.

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

40 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Jul 2028

An estimate. End dates often move.

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

50 to 69 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age 50-69 years old * Postmenopausal woman (absence of menstruation for at least one year, or history of bilateral oophorectomy) * Self-reported height and weight indicating a BMI \>= 18.5 and \< 25 kg/m\^2 * No contraindications to exercise (either no positive responses on the Physical Activity Readiness Questionnaire, or clearance from a health care provider certifying that the participant is healthy enough to exercise) * No history of invasive cancer, other than non-melanoma skin cancer * No history of renal disease * Able to walk without an assistive device * Not within 3 months of major surgery * Able to speak/read/write in English * Has internet access on a computer or mobile device * A trunk fat mass \>= 9.4 kg as indicated by a dual x-ray absorptiometry (DXA) scan * Height and weight indicating a BMI of \>= 18.5 and \< 25 kg/m\^2 verified at the screening visit Exclusion Criteria: * MD Anderson employees that report to the principal investigator of this study * Participants that cannot engage in the exercise program for more than three weeks during the study period * Participants that are currently doing strength exercises that work all major muscle groups (defined as: participants who complete more than 16 repetitions per exercise in their current resistance training regimen, or who don't find their last 1-2 reps to be difficult in their current regimen, or who increase the weight in their current routine).

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Conditions

The condition(s) this trial relates to.

breast carcinoma breast neoplasm breast cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast carcinoma

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.