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BRCA1 MutationNCT03570125

BRCA Main Home Nutritional Intervention-random Study

A study testing Prolon in people with BRCA1 Mutation and BRCA2 Mutation, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Women carrying harmful mutation in BRCA1 or BRCA2 gene are at higher risk to develop breast and/or ovarian cancer than the general population. Many observations lead to the hypothesis that breast cancer risk may be increased in women with elevated plasma insulin-like growth factor 1 (IGF-1) and insulin levels. Read more about this study

Who is it for?
Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
BRCA1 Mutation, BRCA2 Mutation
What is being tested?
Prolon
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteItaly
Study dates
1 Jun 2018to 31 May 2020
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • BRCA1 mutation carrier BRCA 2 mutation carrier

Who cannot join

  • diabetes anorexic under treatment for glycemic control

Trial locations and contacts

1 site in 1 country.

Mario G Mirisola, PhD contact

+393287538270

mario.mirisola@unipa.it

Italy1 site, 1 recruiting
  • AOUP Paolo Giaccone

    Palermo, 90127

    Mario G Mirisola, PhD, +393287538270, mario.mirisola@unipa.it

    Recruiting

Other trials in Italy

About this study

Women carrying harmful mutation in BRCA1 or BRCA2 gene are at higher risk to develop breast and/or ovarian cancer than the general population. Many observations lead to the hypothesis that breast cancer risk may be increased in women with elevated plasma insulin-like growth factor 1 (IGF-1) and insulin levels. Targeting the IGF system is therefore a promising anticancer therapy and a new tool for oncologists. Evidence from bio-gerontology research from our laboratories show that cycles of short-term fasting/starvation (STS) or low calorie diet can improve health span of laboratory animals, whose effect is partly mediated by reduced circulating IGF-1. Investigators in our group have demonstrated that protein consumption, especially animal proteins, increases IGF-1 level and is associated with elevated cancer risk in a US cohort ranging from age 50 to 65 (PMID: 26094889). It was also showed that alternating prolonged fasting and nutrient-rich medium extended yeast lifespan independently of the status of the established pro-longevity genes. Prolonged Fasting (PF) has also been shown in preliminary studies to decrease the side effects of chemotherapy, an effect now being tested in multiple larger randomized clinical trials (PMID: 26590477). The main hypothesis of this proposal is that a combination of protein restriction, fasting, fasting mimicking diet (FMD), and restriction of specific amino acids may be able to decrease cancer incidence in a cohort of people at high risk of developing tumors (BRCA1/2). Our group plan to verify the safety, effectiveness and impact of a specially formulated longevity dietary regimen (low protein fish- and plant-based) and of FMD repeated cycles on the levels of endogenous hormones in a cohort of people at increased cancer risk. Since the duration of the project will not give us the opportunity to directly measure cancer incidence in humans we will test: 1a) the variation of a number of widely recognized susceptibility biomarkers predictive of cancer incidence in a cohort human carriers of BRCA1/2 mutations in response to the dietary interventions; 1b) cancer incidence and progression in genetically engineered mice (K14Cre Brca1flox/flox Trp53+/flox and K14Cre Brca1+/flox Trp53-/- mice) predisposed to develop hereditary breast cancer in response to corresponding dietary interventions. Investigators will also test epigenetic alterations associated with these interventions in: 2a) DNA samples from muscle biopsies of a subgroup of humans; 2b) breast epithelial tissue in mice.

Read the detailed description

The risk. Women carrying harmful mutation in BRCA1 or BRCA2 gene are at higher risk to develop breast and/or ovarian cancer than the general population. 12 percent of all U.S. women are going to develop breast cancer sometime during their lives (Howlader N, Noone AM, Krapcho M, et al. (eds). SEER Cancer Statistics Review, 1975-2011, National Cancer Institute.

Bethesda, MD,), while this risk goes up to 65 percent for women who inherit a BRCA1 mutation and 45 percent for those who inherit a BRCA2 mutation by the age of 70 (PMID: 17416853). Similarly, 1.4 percent of women in the general population who will develop ovarian cancer sometime during their lives whereas 39 percent of women who inherit a BRCA1 mutation and 11 to 17 percent of women who inherit a BRCA2 mutation will develop ovarian cancer by age 70 (PMID: 17416853). The risk associated with these mutations is likely to be underestimated since few studies comparing the risk to develop cancer between general population and mutation carriers have been carried out so far. It must be noted that family history of cancer, which specific BRCA1 or BRCA2 mutation has been inherited and reproductive history play a role in cancer risk.

Modifying the risk. Epidemiologists have found a strong association between obesity and the risk of developing breast cancer in postmenopausal women (Ballard-Barbash R, Berrigan D, Potischman N, Dowling E. Obesity and cancer epidemiology. Springer-Verlag New York, LLC, 2010). On the contrary moderate to high physical activity decreases breast cancer risk in both pre and postmenopausal women (Ballard-Barbash R, Hunsberger S, Alciati MH. Journal of the National Cancer Institute 2009; 101(9):630-643.). It is well known that obesity as well as sedentary lifestyle are two significant predictors of development of insulin resistance and Type 2 diabetes mellitus (T2DM) (PMID: 21602457). The molecular mechanisms for these associations are still unknown, but chronic sustained hyperinsulinemia in these insulin-resistant patients appears to play a central role in the carcinogenesis process. Several studies have also shown an increase in breast cancer risk among women who have increased testosterone levels, reduced levels of sex hormone-binding globulin (SHBG), and hence elevated levels of bioavailable androgens and estrogens not bound to SHBG (PMID: 21330633). Collectively, these observations lead to the hypothesis that breast cancer risk may be increased in women with elevated plasma insulin levels. Many studies have related relatively high plasma IGF-I and low IGF binding protein-3 (IGFBP-3) levels with increased risk of breast cancer in pre-menopausal women (PMID: 9593409), prostate cancer in men (PMID: 9438850), colorectal cancer in men and women (PMID: 10203281), and lung cancer in men and women (PMID: 10793110) as well as in angiogenesis, metastasis and in resistance to chemotherapy (PMID: 16931767; PMID: 23098677). Targeting the IGF system is therefore a promising anticancer therapy and a new tool for oncologists (PMID: 16931767).

Inhibition of GH/IGF1 secretion or action decreases the incidence and the rate of progression of cancers in animal studies.

Dwarf mice deficient in growth hormone receptor have lower incidence and delayed occurrence of neoplastic lesions than their wild-type counterpart. In addition, mice with nonfunctioning GHRH receptor and thus very low GH and IGF1 levels, show almost complete inhibition of growth of transplanted human breast cancer cells (PMID: 8603394).

Evidence from bio-gerontology research from our laboratories show that cycles of short-term fasting/starvation (STS) or low calorie diet can improve health span of laboratory animals, whose effect is partly mediated by reduced circulating insulin-like growth factor 1 (IGF-1) (PMID: 26094889). The Ecuadorian growth hormone receptor deficient cohort, with very low circulating IGF-1 level, show low blood insulin level, higher insulin sensitivity and very low incidence of cancer (PMID: 21325617). Our group has also demonstrated that protein consumption, especially animal proteins, increases IGF1 level and is associated with elevated cancer risk in a US cohort ranging from age 50 to 65 (PMID: 26094889). Finally, evidence is accumulating pointing to Epigenetics as a potential mechanistic link between diet, energy metabolism, and gene expression modulation (PMID: 22152918; PMID: 22444501). The epigenome, even though established at pre-natal level, undergoes several changes throughout the lifetime. The epigenome records a variety of dietary, lifestyle, behavioral, and social cues, providing thus an interface between the environment and the genome.

Being tested
Prolon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProlonDietary supplement

    The diet consists of natural ingredients, which are Generally Regarded As Safe (GRAS). In case the PROLON product will be unavailable at the time of the project we will design fasting mimicking diet without the usage of specifically designed commercial product

Study groups in NCT03570125
Study groupRoleWhat they receive
Dietary intervention armExperimentalgroup will follow an ad libitum diet but, every two months, will follow a 5 day of fasting mimicking diet (PROLON). The diet consists of natural ingredients, which are Generally Regarded As Safe (GRAS). Prolon will be provided for free by L-nutra or in case of unforeseeable budget constraint at one fifth of its commercial value.
Receives: Dietary Supplement: Prolon
no interventionNo interventionControl/Placebo with multivitamin supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IGF1

    IGF1 elisa test

    Measured: 6 months

  2. GH

    GH elisa test

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2018
  2. Study start1 Jun 2018
  3. Primary completion31 May 2019 (estimated)
  4. Study completion31 May 2020 (estimated)

Resources

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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03570125
Sponsor's protocol ID
CEP1:4/2016
Status last verified
Jun 2018
First submitted
11 Jun 2018
Last updated
28 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cheng CW, Adams GB, Perin L, Wei M, Zhou X, Lam BS, Da Sacco S, Mirisola M, Quinn DI, Dorff TB, Kopchick JJ, Longo VD. Prolonged fasting reduces IGF-1/PKA to promote hematopoietic-stem-cell-based regeneration and reverse immunosuppression. Cell Stem Cell. 2014 Jun 5;14(6):810-23. doi: 10.1016/j.stem.2014.04.014.

    PubMed 24905167
  • Brandhorst S, Choi IY, Wei M, Cheng CW, Sedrakyan S, Navarrete G, Dubeau L, Yap LP, Park R, Vinciguerra M, Di Biase S, Mirzaei H, Mirisola MG, Childress P, Ji L, Groshen S, Penna F, Odetti P, Perin L, Conti PS, Ikeno Y, Kennedy BK, Cohen P, Morgan TE, Dorff TB, Longo VD. A Periodic Diet that Mimics Fasting Promotes Multi-System Regeneration, Enhanced Cognitive Performance, and Healthspan. Cell Metab. 2015 Jul 7;22(1):86-99. doi: 10.1016/j.cmet.2015.05.012. Epub 2015 Jun 18.

    PubMed 26094889
  • Levine ME, Suarez JA, Brandhorst S, Balasubramanian P, Cheng CW, Madia F, Fontana L, Mirisola MG, Guevara-Aguirre J, Wan J, Passarino G, Kennedy BK, Wei M, Cohen P, Crimmins EM, Longo VD. Low protein intake is associated with a major reduction in IGF-1, cancer, and overall mortality in the 65 and younger but not older population. Cell Metab. 2014 Mar 4;19(3):407-17. doi: 10.1016/j.cmet.2014.02.006.

    PubMed 24606898

Questions about this trial

What is this clinical trial studying?

A study testing Prolon in people with BRCA1 Mutation and BRCA2 Mutation, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mario G Mirisola, PhD (+393287538270, mario.mirisola@unipa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IGF1 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03570125, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.

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