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NCT03546972
Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants
NA trial testing Behavioral, Psychological or Informational Intervention in Deleterious BRCA1 Gene Mutation in 51 participants. Participants enrolled and being followed up; not accepting new ones.
30 November 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 51 |
| Start date | 17 December 2017 |
| Primary completion | 30 November 2026 |
| Estimated completion | 30 November 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Behavioral, Psychological or Informational Intervention
- Behavioral, Psychological or Informational Intervention
- Questionnaire Administration
Conditions studied
- Deleterious BRCA1 Gene Mutation — all drugs for Deleterious BRCA1 Gene Mutation →
- Deleterious BRCA2 Gene Mutation — all drugs for Deleterious BRCA2 Gene Mutation →
- Ductal Breast Carcinoma In Situ — all drugs for Ductal Breast Carcinoma In Situ →
- Obesity — all drugs for Obesity →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
Adults 30 to 70, female only, with Deleterious BRCA1 Gene Mutation or Deleterious BRCA2 Gene Mutation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Hunger Training as a Self-regulation Strategy in a Comprehensive Weight Loss Program for Breast Cancer Prevention: A Randomized Feasibility Study.
Schembre SM, Jospe MR, Bedrick EJ, Li L, et al · · 2022 · cited 11× · PMID 34893531 · DOI 10.1158/1940-6207.capr-21-0298 -
A Low-Glucose Eating Pattern Improves Biomarkers of Postmenopausal Breast Cancer Risk: An Exploratory Secondary Analysis of a Randomized Feasibility Trial.
Schembre SM, Jospe MR, Giles ED, Sears DD, et al · · 2021 · cited 7× · PMID 34960058 · DOI 10.3390/nu13124508 -
A low-glucose eating pattern is associated with improvements in glycemic variability among women at risk for postmenopausal breast cancer: an exploratory analysis.
Jospe MR, Liao Y, Giles ED, Hudson BI, et al · · 2024 · cited 1× · PMID 38660060 · DOI 10.3389/fnut.2024.1301427
Verify or expand the search:
- PubMed search for NCT03546972
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Deleterious BRCA1 Gene Mutation
Currently open trials in the same condition.
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03546972 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 15 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03546972.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing