Nutritional Intervention and DNA Damage of Patients With HBOC

DNA Damage Clinical Trial

Official title:

Effects of a Nutritional Intervention in DNA Damage of Patients With Hereditary Breast and Ovarian Cancer Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05306002
• Other study ID #: ONCONOV001
• Status: Completed
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2024
• Source: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Breast and Ovarian Cancer Syndrome (HBOC) is a genetic disease characterized by mutations in tumor suppressor genes such as BRCA1 and BRCA2, elevation of Reactive Oxygen Species (ROS), inflammation and DNA damage; all this as a result of the pathology itself. Antineoplastic treatments and changes in body composition such as malnutrition, cachexia and obesity lead to an increase of the inflammatory state. The induction of epigenetic changes by a nutritional intervention suggests that an hypo caloric diet, complex carbohydrates, polyunsaturated fatty acids, some amino acids, and some vitamins, minerals and polyphenols as well, can reduce DNA damage because of the interaction between mechanisms related with DNA stability and reparation, cellular replication, induction of apoptosis, and antioxidant systems. Previous studies report that using polyphenols supplements can reduce de DNA damage, but when the administration is only through food there's no benefit at all. So the aim of this study is to assess if the use of different micronutrients and polyphenols in conjoint can make synergism and reduce de DNA damage without the need of supplements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 31, 2022
• Est. primary completion date: March 22, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients with end-stage chronic kidney failure, heart failure, liver failure, rheumatoid arthritis, non-inherited AC or HIV.
• Patients who carry out a structured exercise plan (rehabilitation) at the time of inclusion in the study.
• Patients who carry out a structured eating plan (adherence to diet) or who are consuming a food supplement at the time of inclusion in the study.
• Patients with significant primary clinical disorders: hematological (hemoglobin <13 in men and <12 in women), renal (creatinine> 3), neurological (other than epilepsy).

Related Conditions & MeSH terms

• DNA Damage
• Hereditary Breast and Ovarian Cancer Syndrome
• Nutrition Therapy
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Mexico	María Fernanda Díaz Yáñez	Mexico City	Benito Juárez

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body composition change	A bioelectrical impedance analysis will be used to assess the body composition through the reactance and resistance values (both measured in Ohm), before and after nutritional intervention.	12 weeks
Secondary	Muscular strength change	A hand grip dynamometer will be used to assess the muscular strength in kg, both before and after the nutritional intervention.	12 weeks
Secondary	Dietary change: Energy	A 24-hour recalls will be performed to evaluate amount of energy (measured in kilocalories), before and after the nutritional intervention.	12 weeks
Secondary	Dietary change: Macronutrients	A 24-hour recalls will be performed to evaluate amount of carbohydrate, protein and fat (all measured in percentage and grams), before and after the nutritional intervention.	12 weeks
Secondary	Dietary change: Micronutrients	A 24-hour recalls will be performed to evaluate amount of vitamin E, calcium, zinc and magnesium (all measured in milligrams), before and after the nutritional intervention.; A 24-hour recalls will be performed to evaluate amount of folate, vitamin A and D, selenium, lycopene, and flavones (all measured in micrograms), before and after the nutritional intervention.	12 weeks