Nutritional Intervention and DNA Damage of Patients With HBOC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HBOC Syndrome DNA Damage Nutrition Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antioxidant therapy

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).

Group Type OTHER

Antioxidant therapy

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Antioxidant therapy

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No