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Dietary Intervention and BRCA Penetrance

NCT03066856 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 502

Last updated 2021-10-04

No results posted yet for this study

Summary

Insulin-like growth factor I (IGF-I) and other markers of insulin resistance (IRm) might modulate the penetrance of BRCA genes mutation.

The investigators have designed a demonstration project with BRCA mutation carriers (with or without a previous diagnosis of breast cancer) to test:

1. whether a lifestyle intervention significantly reduceIGF-I and the other IRm (randomized trial).
2. whether mutation carriers with a previous diagnosis of breast cancer have higher IRm than carriers without breast cancer (case-controlstudy).
3. whether IRm and their change over time affect subsequent breast cancer incidence and prognosis (cohort follow-up).

The investigators expect to significantly reduce IGF-I and IRm, to find that BRCA mutation carriers with a previous breast cancer have higher IRm levels, and, in the long term, that women with persistent higher IRm levels have higher penetrance and worst prognosis.

Confirming a significant reduction of IRm and the impact of their levels on prognosis would help to develop primary prevention recommendations for high risk families.

Conditions

  • Dietary Modification
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Breast Cancer

Interventions

OTHER

Dietary intervention

The main aim of the trial is to reduce serum levels of IGF-I and IRm with a a low- calorie and low-protein diet. In humans, calorie restriction alone does not seem to significantly lower IGF-I; protein restriction is also required. In detail, recommendations for participants included in the intervention arm include: * reducing protein intake, mainly milk and animal protein (except fish), down to 10-12% of total calorie intake. * reducing high glycemic index food and high insulinemic foods. * reducing sources of saturated fat (red and processed meat, milk and dairy products). * eating mostly food of plant origin, with a wide variety of seasonal products.

Sponsors & Collaborators

  • Istituto Oncologico di Bari

    collaborator UNKNOWN

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03066856 on ClinicalTrials.gov