Clinical trial NCT05306002: Nutritional Intervention and DNA Damage of Patients With HBOC
Official title: Effects of a Nutritional Intervention in DNA Damage of Patients With Hereditary Breast and Ovarian Cancer Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HBOC Syndrome
DNA Damage
Nutrition Therapy
Keywords: HBOC Syndrome
DNA Damage
Nutrition Therapy
Lead sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Sponsor class: OTHER_GOV
First posted: 2022-03-31
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: DNA damage change
timeFrame: 12 weeks
Secondary outcomes:
measure: Body composition change
timeFrame: 12 weeks
measure: Muscular strength change
timeFrame: 12 weeks
measure: Dietary change: Energy
timeFrame: 12 weeks
measure: Dietary change: Macronutrients
timeFrame: 12 weeks
measure: Dietary change: Micronutrients
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: María Fernanda Díaz Yáñez
state: Benito Juárez
Study officials:
affiliation: CMN "20 de Noviembre"
name: María Fernanda Díaz Yáñez, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: CMN "20 de Noviembre"
name: Martha Fernanda Medero López, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: CMN "20 de Noviembre"
name: Juan Antonio Pineda Juárez, PhD
role: STUDY_DIRECTOR
affiliation: CMN "20 de Noviembre"
name: Martha Orozco Quiyono, MSc
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Mónica Escamilla Tilch, PhD
role: STUDY_CHAIR
References:
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citation: 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.
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.