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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am at high risk for breast cancer due to genetic factors or previous conditions.
Select...
I have not had a period for 12 months or have had both ovaries removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 • NCT0181707513%
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)
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.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,463 Total Patients Enrolled
9 Trials studying Obesity
2,467 Patients Enrolled for Obesity
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,313 Total Patients Enrolled
48 Trials studying Obesity
31,437 Patients Enrolled for Obesity
Karen M Basen-EngquistPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
822 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 at high risk for breast cancer due to genetic factors or previous conditions.I am currently receiving treatment for a cancer that is not nonmelanoma skin cancer.I have been diagnosed with type 1 or type 2 diabetes.I have been treated with GLP-1 receptor agonists.I have not had a period for 12 months or have had both ovaries removed.You can take pictures with a time stamp using a digital device.Your current measured body mass index (BMI) is less than 27 kg/m^2.I have only used basal insulin, except for short-term treatments.I am at high risk for breast cancer due to my genetic history or previous conditions.I have not had a period for 12 months or have had both ovaries removed.Your blood sugar levels are too high when you haven't eaten for a while, and your HbA1c levels are above 7%.I am not willing to use a device that needs daily finger pricks for blood tests.Your body mass index (BMI) is 27 or higher.Your body mass index (BMI) is 27 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Group A (DPP)
- Group 2: Group B (DPP-HT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT03546972 — N/A
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