Deleterious BRCA1 Gene MutationNCT03546972
Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants
A study testing Behavioral, Psychological or Informational Intervention and Questionnaire Administration in people with Deleterious BRCA1 Gene Mutation and Deleterious BRCA2 Gene Mutation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, Ductal Breast Carcinoma In Situ
- What is being tested?
- Behavioral, Psychological or Informational Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2017to 30 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Choosing Health and Cancer Risk Reduction Through Good Eating and Exercise
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of adding hunger training to the Diabetes Prevention Program (DPP) using the following criteria: accrual rates > 50%, attrition rates < 20% and, in the DPP-plus-hunger training (HT) group, training protocol adherence rates > 75%.
SECONDARY OBJECTIVES:
- Estimate the magnitude of effect sizes and variation in outcome variables for the DPP-only and DPP-plus-HT interventions on changes in weight; in metabolic and breast cancer risk biomarkers (e.g., fasting insulin and blood glucose [BG] levels, levels of glycosylated hemoglobin, insulin resistance, adiponectin, interleukin-6, and C-reactive protein); and in proposed behavioral mediators (e.g., reduction in total energy intake, overall eating frequency, percent of eating events occurring at or below the average fasting blood BG level).
II. Examine the mediation effects of proposed mechanisms of the interventions related to individual-level behavioral measures of eating self-regulation on the proposed outcomes using a multimodal approach of validated questionnaires and reliable ecological momentary assessment method.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP A: Participants take part in DPP once a week over 1 hour for 16 weeks.
GROUP B: Participants take part in DPP once a week over 1 hour for 16 weeks and hunger training once a week during weeks 2-6.
- Conditions
- Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, Ductal Breast Carcinoma In Situ, Obesity, Overweight, Premalignant Lesion
- Being tested
- Behavioral, Psychological or Informational Intervention, Questionnaire Administration
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral, Psychological or Informational InterventionOther
Take part in DDP
Behavioral, Psychological or Informational InterventionOther
Take part in HT
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group A (DPP) | Active comparator | Participants take part in DPP once a week over 1 hour for 16 weeks. Receives: Other: Behavioral, Psychological or Informational Intervention; Other: Questionnaire Administration |
| Group B (DPP-HT) | Experimental | Participants take part in DPP once a week over 1 hour for 16 weeks and hunger training once a week during weeks 2-6. Receives: Other: Behavioral, Psychological or Informational Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by recruitment rate
Measured by percentage of participants who enroll in the study.
Measured: Up to 2 years
Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by drop-out rates
Measured by percentage of participants who leave the study.
Measured: Up to 2 years
Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by completion rates
Measured by percentage of participants who complete the study.
Measured: Up to 2 years
Secondary outcomes (3)
Changes in weight loss
Will use linear regression to study the effects of participant characteristics (i.e., weight history) and their interactions with the treatment groups.
Measured: Baseline to 2 years
Changes in metabolic and breast cancer risk biomarkers
Biomarkers will be assessed through blood draws.
Measured: Baseline to 2 years
Changes in proposed behavioral mediators through survey
Eating patterns will be assessed through survey ASA24 (Automated Self-assessment).
Measured: At baseline and at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start17 Dec 2017
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deleterious BRCA1 Gene MutationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Karen M Basen-Engquist, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546972
- Sponsor's protocol ID
- 2017-0507
- Other IDs
- NCI-2018-01275, 2017-0507, R21CA215415
- Status last verified
- Oct 2026
- First submitted
- 14 May 2018
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jospe MR, Liao Y, Giles ED, Hudson BI, Slingerland JM, Schembre SM. A low-glucose eating pattern is associated with improvements in glycemic variability among women at risk for postmenopausal breast cancer: an exploratory analysis. Front Nutr. 2024 Apr 10;11:1301427. doi: 10.3389/fnut.2024.1301427. eCollection 2024.
PubMed 38660060