Nutritional Intervention and DNA Damage of Patients With HBOC

NCT05306002 | Completed DMC

• 1 other identifier: ONCONOV001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Breast and Ovarian Cancer Syndrome (HBOC) is characterized by mutations in tumor suppressor genes such as BRCA1 and BRCA2, which increase the carrier's risk of developing breast and ovarian cancer, especially before 40. In this pathology the DNA damage is increased because there is a state of chronic inflammation, plus the antineoplastic treatments and changes in body composition result in oxidative stress. The inductions of epigenetic changes by a nutritional intervention with an specific distribution of macronutrients, micronutrients and polyphenols, not only ensures an optimal nutritional status, but also shows a decrease in oxidative stress, and therefore in DNA damage. The aim of this study is to assess if the DNA damage in patients with HBOC decreases after the nutritional intervention.

Conditions

HBOC Syndrome; DNA Damage; Nutrition Therapy

Keywords

HBOC Syndrome; DNA Damage; Nutrition Therapy

Outcome Measures

Primary Outcomes (1)

• DNA damage change

  A blood sample will be taken to assess DNA damage (ELISA) by 8-hydroxy-2-deoxyguanosine (8-OHdG), a modified nitrogen base indicating oxidative damage to DNA, before and after nutritional intervention.

  12 weeks

Secondary Outcomes (5)

• Body composition change

  12 weeks

• Muscular strength change

  12 weeks

• Dietary change: Energy

  12 weeks

• Dietary change: Macronutrients

  12 weeks

• Dietary change: Micronutrients

  12 weeks

Study Arms (1)

Antioxidant therapy

OTHER

The patient will get a nutritional personalized treatment with the following characteristics: hypocaloric diet, rich in micronutrients related with DNA reparation and polyphenols, with the next distribution: 45% carbohydrates, 30% lipids, 25% protein, \<10% saturated fats, \>10% unsaturated fats, based on the recommendations of the American Institute for Cancer Research (AICR).

Combination Product: Antioxidant therapy

Interventions

Antioxidant therapy COMBINATION_PRODUCT

Antioxidant therapy based in the following dietary components: Zinc, Selenium, Magnesium, carotenoids, indole-3-carbinol, curcumin, epigalactocatechin, caffeine, resveratrol, lycopene, genistein, phytoestrogens

Antioxidant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients diagnosed with HBOC according to the Mexican Consensus of Breast Cancer
• Patients over 18 years who voluntarily agree to participate in the study and sign the informed consent.

You may not qualify if:

• Patients with end-stage chronic kidney failure, heart failure, liver failure, rheumatoid arthritis, non-inherited AC or HIV.
• Patients with significant primary clinical disorders: hematological (hemoglobin \<13 in men and \<12 in women), renal (creatinine\> 3), neurological (other than epilepsy).

Sponsors & Collaborators

• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado: lead

Study Sites (1)

María Fernanda Díaz Yáñez

Mexico City, Benito Juárez, 03420, Mexico

Location

Related Publications (5)

• Kowalska E, Narod SA, Huzarski T, Zajaczek S, Huzarska J, Gorski B, Lubinski J. Increased rates of chromosome breakage in BRCA1 carriers are normalized by oral selenium supplementation. Cancer Epidemiol Biomarkers Prev. 2005 May;14(5):1302-6. doi: 10.1158/1055-9965.EPI-03-0448.

  PMID: 15894690 BACKGROUND

• Kasai H. Analysis of a form of oxidative DNA damage, 8-hydroxy-2'-deoxyguanosine, as a marker of cellular oxidative stress during carcinogenesis. Mutat Res. 1997 Dec;387(3):147-63. doi: 10.1016/s1383-5742(97)00035-5.

  PMID: 9439711 BACKGROUND

• Gopalakrishnan S, Van Emburgh BO, Robertson KD. DNA methylation in development and human disease. Mutat Res. 2008 Dec 1;647(1-2):30-8. doi: 10.1016/j.mrfmmm.2008.08.006. Epub 2008 Aug 20.

  PMID: 18778722 BACKGROUND

• Ferguson LR, Chen H, Collins AR, Connell M, Damia G, Dasgupta S, Malhotra M, Meeker AK, Amedei A, Amin A, Ashraf SS, Aquilano K, Azmi AS, Bhakta D, Bilsland A, Boosani CS, Chen S, Ciriolo MR, Fujii H, Guha G, Halicka D, Helferich WG, Keith WN, Mohammed SI, Niccolai E, Yang X, Honoki K, Parslow VR, Prakash S, Rezazadeh S, Shackelford RE, Sidransky D, Tran PT, Yang ES, Maxwell CA. Genomic instability in human cancer: Molecular insights and opportunities for therapeutic attack and prevention through diet and nutrition. Semin Cancer Biol. 2015 Dec;35 Suppl(Suppl):S5-S24. doi: 10.1016/j.semcancer.2015.03.005. Epub 2015 Apr 11.

  PMID: 25869442 BACKGROUND

• Higdon JV, Delage B, Williams DE, Dashwood RH. Cruciferous vegetables and human cancer risk: epidemiologic evidence and mechanistic basis. Pharmacol Res. 2007 Mar;55(3):224-36. doi: 10.1016/j.phrs.2007.01.009. Epub 2007 Jan 25.

  PMID: 17317210 BACKGROUND

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• María Fernanda Díaz Yáñez, BSc

  CMN "20 de Noviembre"

  PRINCIPAL INVESTIGATOR

• Martha Fernanda Medero López, BSc

  CMN "20 de Noviembre"

  PRINCIPAL INVESTIGATOR

• Juan Antonio Pineda Juárez, PhD

  CMN "20 de Noviembre"

  STUDY DIRECTOR

• Martha Orozco Quiyono, MSc

  CMN "20 de Noviembre"

  STUDY CHAIR

• Mónica Escamilla Tilch, PhD

  CMN "20 de Noviembre"

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher - Research Coordination

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: March 31, 2022
• Study Start: November 28, 2017
• Primary Completion: March 22, 2020
• Study Completion: December 31, 2022
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)