NCT03066856

Dietary Intervention and BRCA Penetrance

Completed NA Last updated 4 October 2021

What this trial tests

NA trial testing Dietary intervention in Dietary Modification in 502 participants. Completed in 31 December 2018.

Timeline

1 December 2015

Primary endpoint
31 December 2018

31 December 2018

Quick facts

Lead sponsor	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	502
Start date	1 December 2015
Primary completion	31 December 2018
Estimated completion	31 December 2018
Sites	1 location across Italy

Drugs / interventions tested

• Dietary intervention

Conditions studied

• Dietary Modification — all drugs for Dietary Modification →
• BRCA1 Mutation — all drugs for BRCA1 Mutation →
• BRCA2 Mutation — all drugs for BRCA2 Mutation →
• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano — full company profile →

Who can join

Adults 18 to 70, female only, with Dietary Modification or BRCA1 Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Mediterranean Diet: An Update of the Clinical Trials.
   Finicelli M, Di Salle A, Galderisi U, Peluso G. · · 2022 · cited 105× · PMID 35889911 · DOI 10.3390/nu14142956
2. A Dietary Intervention to Lower Serum Levels of IGF-I in <i>BRCA</i> Mutation Carriers.
   Pasanisi P, Bruno E, Venturelli E, Morelli D, et al · · 2018 · cited 20× · PMID 30181513 · DOI 10.3390/cancers10090309
3. Lifestyle Characteristics in Women Carriers of BRCA Mutations: Results From an Italian Trial Cohort.
   Bruno E, Oliverio A, Paradiso A, Daniele A, et al · · 2021 · cited 16× · PMID 33357965 · DOI 10.1016/j.clbc.2020.11.002
4. A Mediterranean Dietary Intervention in Female Carriers of BRCA Mutations: Results from an Italian Prospective Randomized Controlled Trial.
   Bruno E, Oliverio A, Paradiso AV, Daniele A, et al · · 2020 · cited 16× · PMID 33322597 · DOI 10.3390/cancers12123732
5. BRCA1/2 Variants and Metabolic Factors: Results From a Cohort of Italian Female Carriers.
   Oliverio A, Bruno E, Colombo M, Paradiso A, et al · · 2020 · cited 5× · PMID 33266155 · DOI 10.3390/cancers12123584
6. miRNA deregulation and relationship with metabolic parameters after Mediterranean dietary intervention in BRCA-mutated women.
   De Summa S, Traversa D, Daniele A, Palumbo O, et al · · 2023 · cited 3× · PMID 37081976 · DOI 10.3389/fonc.2023.1147190
7. Physical activity and sleep behaviour in women carrying BRCA1/2 mutations.
   Galasso L, Castelli L, Roveda E, Oliverio A, et al · · 2022 · cited 3× · PMID 35896655 · DOI 10.1038/s41598-022-16687-1
8. The Impact of Mediterranean Dietary Intervention on Metabolic and Hormonal Parameters According to <i>BRCA1/2</i> Variant Type.
   Oliverio A, Radice P, Colombo M, Paradiso A, et al · · 2022 · cited 2× · PMID 35356420 · DOI 10.3389/fgene.2022.820878