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

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ClinicalTrials.gov Identifier: NCT03549273
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Catalysis SL

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.

Condition or disease Intervention/treatment Phase
Carcinoma Neoplasia; Intraepithelial, Cervix Glandular Neoplasms Epithelial Neoplasm Neoplasms Dietary Supplement: Glizigen® + Ocoxin-Viusid® Phase 2

Detailed Description:
Main objective: To evaluate the effect of the combination of Glizigen® and Ocoxin®-Viusid® in the treatment of high-grade cervical intraepithelial lesions. Specific objectives: 1. To evaluate the overall response (colposcopic, histological and virological) in patients treated with the combination of the natural products Glizigen® and Ocoxin®-Viusid® in the treatment of high-grade cervical intraepithelial lesions. 2. Evaluate the colposcopic response in patients treated with the combination of natural products. 3. Evaluate the histological response in patients treated with the combination of natural products after conization. 4. Evaluate the virological response in patients treated with the combination of natural products. 5.Describe adverse events during treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of the Combination of the Natural Products Glizigen® and Ocoxin®-Viusid® in the Treatment of High-grade Cervical Intraepithelial Lesions. Phase II
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Glizigen® spray + Ocoxin-Visuid® oral solution
Dietary Supplement: Glizigen® + Ocoxin-Viusid®
  • 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.




Primary Outcome Measures :
  1. Lesion progression [ Time Frame: 9 months ]

    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).

  2. Lesion progression [ Time Frame: 9 months ]

    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).

  3. Lesion progression [ Time Frame: 9 months ]

    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).


Secondary Outcome Measures :
  1. Colposcopy response [ Time Frame: 9 months ]
    Complete Response: Disappearance of the initial lesion and no new lesions appear; Partial Response: Reduction between 30 to 50% or more of the initial lesion and no new lesions appear; Stable Disease: Equal morphometry or minor reduction 30% of the initial lesion; Progressive Disease: Increased diameter of the lesion The lesion extends to one or more quadrants that were not in the initial lesion).

  2. Histological Response [ Time Frame: 9 months ]
    Complete Response: Disappearance of initial injury No degree of CIN; Partial Response: Reduction of CIN to one degree or more; Stable Illness: Same degree of initial injury remains; Progressive Disease: Increase by one degree lesion of CIN or presence of histological signs of invasion).

  3. Virological response [ Time Frame: 9 months ]
    Complete response: Viral genotype: Negative result for the detection of human papillomavirus (HPV) with high or low oncogenic risk and Viral load: Not detectable; Partial response: Viral genotype: No detection of viral genotypes of high oncogenic risk (16, 18, 31 , 33, 45, 52 and 58) identified in the initial examination, but positive to HPV of low oncogenic risk and viral load: Reduction of the value of the viral load in at least one logarithm of base 10; Stable Disease: Viral genotype: Se maintain the initial genotypes and viral load: Same result as the initial examination, no change in the viral load values; Progressive Disease: Viral genotype: The initial genotypes are maintained or the appearance of one or more oncogenic genotypes and viral load: genotypes initials show an increase in the viral load value in at least one logarithm of base 10. Other oncogenic genotypes appear with viral load values greater than or equal to 103 copies/ml)

  4. Adverse Events (AE) [ Time Frame: 9 months ]
    The AE will measure as: -Occurrence of an AE in the patient (Yes/No) -Description of the AE (Name of the AE presented) -Duration of the AE (Difference of dates between the start and end of the AE) -Intensity of the AE (Classification according to CECMED Regulation 45/2007 in: Mild, Moderate, and Severe) -Gravity of AE (Serious or Not serious. Considering serious adverse events those that: 1.Produce the patient' death, 2.Life-threatening, 3.Hospitalization or prolongation of hospitalization indicated, 4. Produce significant or persistent disability, 5.Produce birth defect or congenital anomaly) -Attitude respect to the treatment under study (No changes, Dose modification, Temporary interruption of the treatments under study, Definitive interruption of the treatments under study). -Result of the EA (Recovered, improved, persists or sequels) -Causality Relationship (Definitive, Very likely, Probable, Possible, Not related, Unknown)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients that meet the diagnostic criteria.
  2. Patients with age ≥18 years.
  3. Patients with residual lesion greater than 3 mm after the initial punch, measurable by video colposcopy and with major changes (Criteria from Rio 2011).
  4. Patients that have a positive test to the oncogenic virus of the human papilloma (16, 18, 31, 33, 45, 52 and 58).
  5. Patients who give their informed consent to participation in writing.
  6. Patients who consent to perform the conization according to the study schedule.
  7. 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549273


Contacts
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Contact: Águeda Santana Martínez 7 690-7225 aguesam@infomed.sld.cu
Contact: ivis Mendoza Hernández 7 690-7225 ivis@cencec.sld.cu

Locations
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Cuba
Our Lady of Rule No. 52 &/Remedios and Quiroga, Luyano Recruiting
Havana, Cuba, 10500
Contact: Águeda Santana, Dr.    +53-76907225    aguesam@infomed.sld.cu   
Principal Investigator: Águeda Santana Martínez, Dr.         
Sub-Investigator: Ivis Mendoza Hernández, Ms.C         
Sub-Investigator: Elena García López, Ms.C         
Principal Investigator: Daimy Bajo Cardoso, Dr.         
Sub-Investigator: Julián Rodríguez Álvarez, Ms.C         
Sponsors and Collaborators
Catalysis SL

Publications:
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Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT03549273     History of Changes
Other Study ID Numbers: OOS-GLZ-2018
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catalysis SL:
carcinoma
intraepithelial cervix lesions
Oxidative Stress
Ocoxin Viusid
Glizigen Spray

Additional relevant MeSH terms:
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Neoplasms
Neoplasms, Glandular and Epithelial
Cervical Intraepithelial Neoplasia
Neoplasms by Histologic Type
Carcinoma in Situ
Carcinoma