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Hunger training may help cut breast cancer risk in obese women

NCT ID NCT03546972

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This pilot study looks at whether adding hunger training to a standard diabetes prevention program helps obese women at high risk for breast cancer lose weight and lower their cancer risk. About 51 participants will learn weight-loss strategies and how to recognize true hunger. The main goal is to see if this approach is practical and effective.

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

51 people

The number who actually took part.

Started

Dec 2017

Expected to finish

Nov 2026

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

30 to 70 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: * Body Mass Index (BMI) \>= 27 kg/m\^2. * At high risk of developing breast cancer defined by one or more of the following: Gail model lifetime risk \> 20% or a 5 year risk \>1.66%, a history of deleterious BRCA1/2 mutation or mantle radiation, a history of ductal cancer in situ, or a history of high risk premalignant breast lesion. * 12 months without a period/menstrual cycle or having had a bilateral oophorectomy. * Ability to take digital time stamped photos. * Internet access (daily). * Reports being proficient in English (can read/write and speak fluently). Exclusion Criteria: * Previous participation in this trial. Participation is defined as screening. Re-screening is not allowed except for individuals excluded for BMI. Patients previous screened as ineligible due to BMI are allowed to be re-screened and enrolled if eligible. * Has a current measured BMI less than 27 kg/m\^2. * Reports being unwilling to use Continuous Glucose Monitor (CGM), which requires daily blood sampling by finger pricks. * Currently being actively treated for cancer other than nonmelanoma skin cancer. * Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests. * Reported current diagnosis or history of type I diabetes or type 2 diabetes. * Reported use of oral antidiabetic agents (OADs). * Current use of any drug (except metformin) or anticipated change in concomitant medication, which the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids). * Previous or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator). * Previous or current treatment with GLP-1 receptor agonists (e.g. exenatide, liraglutide). * Fasting blood glucose level \> 126 and glycosylated hemoglobin (HbA1c) \> 7%. * Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.

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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

  • 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.