Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05306002
Other study ID # ONCONOV001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01677169 - Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Heavy Smokers Phase 2
Recruiting NCT04372914 - Prevention of Oral DNA Damage by Black Raspberries N/A
Terminated NCT03893617 - Brief Stresses Experimental Study Phase 1
Completed NCT03319654 - Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle N/A
Active, not recruiting NCT06204523 - Prospective Validation of a DNA Damage Repair-Hippo Pathway Signature in Patients With Advanced Gastric Cancer
Completed NCT02696811 - The Effects of Foods on Cell Damage Study N/A
Completed NCT01461395 - Polscope Sperm: A Non-invasive Method to Assess DNA Damage in Individual Sperm N/A
Recruiting NCT04081428 - Using Breath, Cell Free DNA and Image Analysis to PRedIct Normal TissUe and Tumour Response During Prostate Cancer SBRT
Not yet recruiting NCT05558046 - Predictive Value of Granulosa Cell DNA Damage in the Success of Assisted Reproductive Technique
Recruiting NCT04795440 - Comparison of ICSI Outcomes in Cycles Using Testicular and Ejaculate Sperm From Couples With High SDF N/A
Completed NCT04772703 - DNA Damage in Critically Ill COVID-19 Patients
Completed NCT05111717 - The Effect of Desfluran On Global Dna Methylation
Recruiting NCT05596149 - Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa N/A
Recruiting NCT03908736 - Thinking Zinc: a Study of Zinc Supplements on the Navajo Nation N/A
Completed NCT04721938 - Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment N/A
Recruiting NCT03652142 - Predictive Biomarkers for Response to Nivolumab in Head and Neck Squamous Cell Carcinoma
Completed NCT00854178 - Toxicogenomic and Immunocytotoxic Effects of Propofol and Isoflurane Anesthetics in Patients Undergoing Elective Surgery Phase 4
Active, not recruiting NCT05277961 - Quantification of DNA Repair Products in the Urine After Ultraviolet Radiation of the Skin N/A
Completed NCT02058082 - Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage N/A
Completed NCT05055154 - Oxidative Stress and L-CBMN Cytome Assay in Obese After 3 Weeks VLCD N/A