Evaluation Glizigen® and Ocoxin®-Viusid® in High-grade Cervical Intraepithelial Lesions

NCT03549273 | Recruiting Phase 2 DMC

• 1 other identifier: OOS-GLZ-2018
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II clinical trial, monocentric, not controlled, in patients with high grade cervical intraepithelial lesions. A total of 62 patients with a diagnosis of CIN II, III or carcinoma in situ will be included. It is expected that with the combination of natural products Glizigen® and Ocoxin®-Viusid® at least 60% of patients with treated intraepithelial lesions (IEL) have a global response (complete or partial), with elimination of the human papillomavirus and the viral load.

Conditions

Carcinoma; Neoplasia; Intraepithelial, Cervix; Glandular Neoplasms; Epithelial Neoplasm; Neoplasms

Keywords

carcinoma; intraepithelial cervix lesions; Oxidative Stress; Ocoxin Viusid; Glizigen Spray

Outcome Measures

Primary Outcomes (3)

• Lesion progression

  Colonoscopy. The categories will analyze as: * Complete Response-CR (Disappearance of the initial lesion and no new lesions appear). * Partial Response-PR (Reduction between 30 to 50% or more of the initial lesion and no new lesions appear). * Stable disease-SD (Same morphometry or reduction of less than 30% of the initial lesion). * Progressive Disease-PD (Increase in the diameter of the lesion The lesion extends to one or more quadrants that were not in the initial lesion. It will be considered progressive disease when at least two of the response variables are present.The variable viral load will always be present).

  9 months

• Lesion progression

  Histology. The categories will analyze as: * CR (Disappearance of the initial lesion No degree of Cervical intraepithelial Neoplasia (CIN)). * PR (Reduction of CIN to one degree or more). * SD (Same degree of initial lesion is maintained). * PD (Increase in one degree of the lesion of CIN or presence of histological signs of invasion\] It will be considered progressive disease when at least two of the response variables are present. The variable viral load will always be present).

  9 months

• Lesion progression

  Virological. The categories will analyze as: * CR (Viral genotype- VG: Negative Human Papillomavirus (HPV) detection high or low oncogenic risk and Viral load: Not detectable). * PR (VG: No detection of viral genotypes of high oncogenic risk identified in the initial examination, but positive to HPV of low oncogenic risk Viral load: Reduction of the value of the viral load in at least one base logarithm 10). * SD (VG: Initial genotypes are maintained Viral load: Equal result than the initial examination, no change in the viral load values). * PD (VG: Initial genotypes or appearance of one or more oncogenic genotypes are maintained Viral load: Initial genotypes show an increase in viral load value in at least one base 10 logarithm. Other oncogenic genotypes appear with viral load values greater than or equal to 103 copies / ml.\] It will be considered progressive disease when at least two of the response variables are present.The variable viral load will always be present).

  9 months

Secondary Outcomes (4)

• Colposcopy response

  9 months

• Histological Response

  9 months

• Virological response

  9 months

• Adverse Events (AE)

  9 months

Study Arms (1)

Treatment

EXPERIMENTAL

Glizigen® spray + Ocoxin-Visuid® oral solution

Dietary Supplement: Glizigen® + Ocoxin-Viusid®

Interventions

Glizigen® + Ocoxin-Viusid® DIETARY_SUPPLEMENT

* Glizigen® spray, topical use, 2 times a day for 6 months with an interruption for 2 months at the end of the third month. * Ocoxin®-Viusid® 60 ml daily (1 vial every 12 hours) by oral route for 8 months, preferably administered after breakfast and lunch, without interruption.

Treatment

Eligibility Criteria

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

You may qualify if:

• Patients that meet the diagnostic criteria.
• Patients with age ≥18 years.
• Patients with residual lesion greater than 3 mm after the initial punch, measurable by video colposcopy and with major changes (Criteria from Rio 2011).
• Patients that have a positive test to the oncogenic virus of the human papilloma (16, 18, 31, 33, 45, 52 and 58).
• Patients who give their informed consent to participation in writing.
• Patients who consent to perform the conization according to the study schedule.
• Patients with normal laboratory parameters within the limits established in the institution (complete blood count, platelets and erythrosedimentation. In the case of male sex (vasectomy, use of condoms) while the treatment lasts.

You may not qualify if:

• Patients who have received surgical, ablative, radiant, immunomodulatory or chemotherapy treatment 30 days before recruitment.
• Patients pregnant or breastfeeding.
• Patients with acute cervico-vaginal infections.
• Patients with positive serology known to HIV and/or syphilis.
• Patients with diseases that compromise the state of consciousness or their possibility of collaboration.
• Patients with a history of severe allergic history.
• Patients who are participating in another research.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

Our Lady of Rule No. 52 &/Remedios and Quiroga, Luyano

Havana, 10500, Cuba

RECRUITING

Related Publications (7)

• de Villiers EM. Cross-roads in the classification of papillomaviruses. Virology. 2013 Oct;445(1-2):2-10. doi: 10.1016/j.virol.2013.04.023. Epub 2013 May 16.

  PMID: 23683837 BACKGROUND

• A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66. doi: 10.1002/sim.721.

  PMID: 11252008 BACKGROUND

• Bornstein J, Bentley J, Bosze P, Girardi F, Haefner H, Menton M, Perrotta M, Prendiville W, Russell P, Sideri M, Strander B, Tatti S, Torne A, Walker P. 2011 colposcopic terminology of the International Federation for Cervical Pathology and Colposcopy. Obstet Gynecol. 2012 Jul;120(1):166-72. doi: 10.1097/AOG.0b013e318254f90c.

  PMID: 22914406 BACKGROUND

• Hernandez-Garcia S, Gonzalez V, Sanz E, Pandiella A. Effect of Oncoxin Oral Solution in HER2-Overexpressing Breast Cancer. Nutr Cancer. 2015;67(7):1159-69. doi: 10.1080/01635581.2015.1068819. Epub 2015 Aug 4.

  PMID: 26241555 BACKGROUND

• Diaz-Rodriguez E, Hernandez-Garcia S, Sanz E, Pandiella A. Antitumoral effect of Ocoxin on acute myeloid leukemia. Oncotarget. 2016 Feb 2;7(5):6231-42. doi: 10.18632/oncotarget.6862.

  PMID: 26756220 BACKGROUND

• Vilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59. doi: 10.1111/j.1478-3231.2006.01411.x.

  PMID: 17311621 BACKGROUND

• Stillo M, Carrillo Santisteve P, Lopalco PL. Safety of human papillomavirus vaccines: a review. Expert Opin Drug Saf. 2015 May;14(5):697-712. doi: 10.1517/14740338.2015.1013532. Epub 2015 Feb 18.

  PMID: 25689872 BACKGROUND

MeSH Terms

Conditions

Carcinoma; Uterine Cervical Dysplasia; Neoplasms, Glandular and Epithelial; Neoplasms

Interventions

Ocoxin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Precancerous Conditions; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Águeda Santana Martínez

CONTACT

7 690-7225; aguesam@infomed.sld.cu

ivis Mendoza Hernández

CONTACT

7 690-7225; ivis@cencec.sld.cu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 7, 2018
• Study Start: March 11, 2019
• Primary Completion: December 15, 2024
• Study Completion: January 15, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CU (1)