CarcinomaPhase 2NCT03549273
Evaluation Glizigen® and Ocoxin®-Viusid® in High-grade Cervical Intraepithelial Lesions
A Phase 2 study testing Glizigen® + Ocoxin-Viusid® in people with Carcinoma and Neoplasia; Intraepithelial, Cervix, run by Catalysis SL at 1 site in Cuba.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carcinoma, Neoplasia; Intraepithelial, Cervix, Glandular Neoplasms
- What is being tested?
- Glizigen® + Ocoxin-Viusid®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCuba
- Study dates
- 11 Mar 2019to 15 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Cuba1 site, 1 recruiting
- Recruiting
Our Lady of Rule No. 52 &/Remedios and Quiroga, Luyano
Havana, 10500
Águeda Santana, Dr., +53-76907225, aguesam@infomed.sld.cu
Águeda Santana Martínez, Dr.
About this study
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
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.
Read the 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.
- Conditions
- Carcinoma, Neoplasia; Intraepithelial, Cervix, Glandular Neoplasms, Epithelial Neoplasm, Neoplasms
- Being tested
- Glizigen® + Ocoxin-Viusid®
- Keywords
- carcinoma, intraepithelial cervix lesions, Oxidative Stress, Ocoxin Viusid, Glizigen Spray
- Medical subject headings
- Carcinoma, Uterine Cervical Dysplasia, Neoplasms, Glandular and Epithelial, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Glizigen® spray + Ocoxin-Visuid® oral solution Receives: Dietary Supplement: Glizigen® + Ocoxin-Viusid® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 9 months
Secondary outcomes (4)
Colposcopy response
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).
Measured: 9 months
Histological Response
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).
Measured: 9 months
Virological response
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)
Measured: 9 months
Adverse Events (AE)
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)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start11 Mar 2019
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549273
- Sponsor's protocol ID
- OOS-GLZ-2018
- Status last verified
- Feb 2024
- First submitted
- 25 May 2018
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 23683837A'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.
PubMed 11252008Bornstein 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.
PubMed 22914406Hernandez-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.
PubMed 26241555Diaz-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.
PubMed 26756220Vilar 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.
PubMed 17311621Stillo 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.
PubMed 25689872
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03549273
- Acronym / sponsor ID
- OOS-GLZ-2018
- Conditions
- Carcinoma, Neoplasia; Intraepithelial, Cervix, Glandular Neoplasms, Epithelial Neoplasm, Neoplasms
- Keywords
- carcinoma, intraepithelial cervix lesions, Oxidative Stress, Ocoxin Viusid, Glizigen Spray
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Glizigen® + Ocoxin-Viusid®Glizigen® spray + Ocoxin-Visuid® oral solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Treatment |
Primary outcome
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).
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).
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).
4 secondary outcomes
Colposcopy response
Time frame: 9 months
Histological Response
Time frame: 9 months
Virological response
Time frame: 9 months
Adverse Events (AE)
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 23683837de 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.
- Background: PubMed 11252008A'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.
- Background: PubMed 22914406Bornstein 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.
- Background: PubMed 26241555Hernandez-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.
- Background: PubMed 26756220Diaz-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.
- Background: PubMed 17311621Vilar 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.
- Background: PubMed 25689872Stillo 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glizigen® + Ocoxin-Viusid® in people with Carcinoma and Neoplasia; Intraepithelial, Cervix, run by Catalysis SL at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Águeda Santana Martínez (7 690-7225, aguesam@infomed.sld.cu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion progression (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03549273, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.