Weight-Loss Program for Lowering Breast Cancer Risk in Obesity

Recruiting in Palo Alto (17 mi)

Overseen by Karen M. Basen-Engquist

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This pilot trial studies how well a diabetes prevention program with or without hunger training works in helping to lower breast cancer risk in obese participants. A diabetes prevention program involves learning about and receiving materials on different strategies to encourage weight loss, and hunger training involves learning how to recognize hunger. It is not yet known whether adding hunger training to a diabetes prevention program helps participants control their weight that could reduce the risk of some cancers.

Eligibility Criteria

This trial is for obese individuals at high risk of developing breast cancer, which includes those with a BMI >= 27 kg/m^2, history of certain breast conditions or BRCA1/2 mutations. Participants must have had no menstrual cycle for 12 months or undergone bilateral oophorectomy, be proficient in English, and able to take digital photos. Those actively treated for cancer (except nonmelanoma skin cancer), with diabetes or using specific glucose-affecting drugs cannot join.

Inclusion Criteria

I am at high risk for breast cancer due to genetic factors or previous conditions.

I have not had a period for 12 months or have had both ovaries removed.

Internet access (daily)

Exclusion Criteria

I am taking medication for diabetes in pill form.

I am not taking any medication that affects blood sugar, except possibly metformin.

I am currently receiving treatment for a cancer that is not nonmelanoma skin cancer.

Participant Groups

The study is testing whether adding hunger training to a diabetes prevention program helps obese participants control their weight better and thus reduce the risk of breast cancer. Hunger training teaches how to recognize true hunger cues. The effectiveness will be compared between those who only receive the diabetes prevention program and those who also get hunger training.

Group I: Group B (DPP-HT) Experimental Treatment 2 Interventions

Participants take part in DPP once a week over 1 hour for 16 weeks and hunger training once a week during weeks 2-6.

Group II: Group A (DPP) Active Control 2 Interventions

Participants take part in DPP once a week over 1 hour for 16 weeks.

Diabetes Prevention Program is already approved in United States for the following indications:

🇺🇸 Approved in United States as National Diabetes Prevention Program (NDPP) for:

• Prediabetes
• Type 2 diabetes prevention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References