Esophageal Verrucous Carcinoma, Esophageal Viral Wart, Papilloma Viral Infection, Papillomavirus Infections
Conditions
Keywords
Papillomavirus, Viusid, Glizigen, Papilloma virus Esophageal, Antioxidant
Brief summary
A randomized, double-blind, phase II clinical trial was conducted versus placebo in 110 patients with esophageal human papillomavirus. The experimental group will receive the VIUSID® plus GLIZIGEN® nutritional supplements, administered on an outpatient basis for 3 months. The control group will receive placebo from Viusid plus Glizigen placebo. It is expected that patients in the experimental group have a 30% higher rate of elimination of the virus than patients in the placebo group after treatment. The study will be conducted in the Superior Digestive Tract consultation of the Institute of Gastroenterology of Havana, Cuba.
Detailed description
Initially the study was planned as an adaptive study without seams, phase II / III for 150 patients. 75 in each therapeutic arm. The sample size was calculated with parameters of phase III studies, but establishing an early stop rule, with an intermediate analysis. For the calculation it was taken into account that the expected percentage of elimination of the virus by spontaneous remission in immunocompetent patients, reported internationally is on average 35%. It is intended that in the group of patients to whom VIUSID® plus GLIZIGEN® will be administered, this figure is ≥ 65%. In other words, it is desired to reach a minimum difference of approximately 30% between both groups. Considering a type I error of 5% (adjusted to 2.5% by an intermediate evaluation), a power of 90%, plus 5% of dropouts or losses to follow-up, the minimum number of patients to recruit is 150 patients in total , 75 in each therapeutic arm. However, by decision of the promoter the study was stopped with 55 patients in each arm, 110 patients in total. And established as a phase II trial.
Interventions
DIETARY_SUPPLEMENTViusid®
The VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner.
DIETARY_SUPPLEMENTGlizigen®
The GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.
DIETARY_SUPPLEMENTViusid Placebo
The placebo of VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner .
DIETARY_SUPPLEMENTGlizigen Placebo
The placebo of GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
A double blind. To achieve the masking of the research product, these have been labeled by a computerized randomized balanced list, which will be in the possession of the promoter and the study Biostatistician. The masking will be maintained until the analysis of the data. However, access to the code will be allowed if serious adverse events arise related to the research product.
Intervention model description
Random assignment, through a list obtained by computer. Patients will be randomized in the consultation of the upper digestive tract, once the anatomopathological result with the presence of coilocytes is received, and they meet the established selection criteria.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Older adults between 18 and 65 years of both sexes. * Patients residing in the provinces of Havana, Artemisa and Mayabeque. * Voluntariness of the patient to participate in the study. Informed and written consent. * Women of childbearing age should have negative pregnancy test or use effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation.
Exclusion criteria
* Pregnancy or breastfeeding. * Contraindication to the performance of upper digestive endoscopy. * Psychiatric conditions that do not favor the administration of treatment and follow-up. * History of hypersensitivity to another similar product. * Severe acute allergic states. * Patients with concomitant diagnosis of esophageal tumor or other causes of infectious esophagitis. * Present an associated chronic illness in the decompensation phase (heart disease, diabetes, hypertension, renal failure, AIDSl). * Patients who are receiving another product under investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample | 3 months | Absence of coilocytes / papilloma in the paraffin sample |
| Clinical negativization of the virus in esophageal mucosal tissue sample | 3 months | Negativization of the virus in fresh sample of the mucosa in the PCR study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of esophageal pathology | 3 months | Acanthosis: Yes or No |
| Toxicity due to the Treatment administered | 3 months | It will be determined through the reporting of adverse events that are presented to the research product |
Countries
Cuba
Outcome results
None listed