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Weight-Loss Program for Lowering Breast Cancer Risk in Obesity

N/A
Waitlist Available
Led By Karen M Basen-Engquist
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At high risk of developing breast cancer defined by Gail model lifetime risk > 20% or a 5 year risk >1.66%, history of deleterious BRCA1/2 mutation or mantle radiation, history of ductal cancer in situ, or history of high risk premalignant breast lesion
12 months without a period/menstrual cycle or having had a bilateral oophorectomy
Must not have
Current use of any drug (except metformin) or anticipated change in concomitant medication, which could interfere with the glucose metabolism (e.g. systemic corticosteroids)
Currently being actively treated for cancer other than nonmelanoma skin cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how well a weight-loss program with or without hunger-training helps lower the risk of breast cancer in obese participants.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves behavioral interventions like education on weight loss strategies and recognizing hunger signals rather than medication, side effects are minimal but may include potential psychological discomfort from lifestyle changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at high risk for breast cancer due to genetic factors or previous conditions.
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I have not had a period for 12 months or have had both ovaries removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medication that affects blood sugar, except possibly metformin.
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I am currently receiving treatment for a cancer that is not nonmelanoma skin cancer.
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I have been diagnosed with type 1 or type 2 diabetes.
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I have been treated with GLP-1 receptor agonists.
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I am not willing to use a device that needs daily finger pricks for blood tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by completion rates
Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by drop-out rates
Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by recruitment rate
Secondary study objectives
Changes in metabolic and breast cancer risk biomarkers
Changes in proposed behavioral mediators through survey
Changes in weight loss

Side effects data

From 2020 Phase 3 trial • 177 Patients • NCT01817075
13%
Rash maculo-papular
10%
Skin and subcutaneous tissue disorders - Other, specify
1%
Mucositis oral
1%
Sepsis
1%
Skin ulceration
1%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (CHG Cleansing Wipe)
Arm II (Control)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group B (DPP-HT)Experimental Treatment2 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 Control2 Interventions
Participants take part in DPP once a week over 1 hour for 16 weeks.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,194 Total Patients Enrolled
9 Trials studying Obesity
2,467 Patients Enrolled for Obesity
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,950 Total Patients Enrolled
50 Trials studying Obesity
32,217 Patients Enrolled for Obesity
Karen M Basen-EngquistPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
810 Total Patients Enrolled

Media Library

Diabetes Prevention Program Clinical Trial Eligibility Overview. Trial Name: NCT03546972 — N/A
Obesity Research Study Groups: Group A (DPP), Group B (DPP-HT)
Obesity Clinical Trial 2023: Diabetes Prevention Program Highlights & Side Effects. Trial Name: NCT03546972 — N/A
Diabetes Prevention Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT03546972 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT03546972 — N/A
~11 spots leftby Nov 2026
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