CIN1, CIN2, Dysplasia, Human Papilloma Virus
Conditions
Keywords
AHCC, nutritional supplement, HPV
Brief summary
This is a phase II randomized, double-blind placebo-controlled, crossover trial. The primary outcome of this trial is achieving durable eradication persistent high risk HPV infection determined by HPV negative test results achieved while on active treatment with AHCC and maintained for 6 month post supplementation and 12 months post completion of AHCC treatment compared to placebo.
Detailed description
This is a phase II randomized, double-blind placebo-controlled, crossover trial. The primary outcome of this trial is achieving durable eradication HPV infection determined by HPV negative test results achieved while on active treatment with AHCC and maintained for 6 month post supplementation and 12 months post completion of AHCC treatment for Group 1. We will follow all patients for at least 12 months and up to 30 months depending on success of achieving a negative HPV testing results. After receiving AHCC 3 grams x 6 months if positive at the end of 12 months of study treatment, they are considered a treatment failure. If negative after completion of 6 months of AHCC supplementation + 6 months of placebo, they will continue on study for another six months (2 visits) to confirm they remain HPV negative and durable response. Group 2 will serve as untreated control for all time points (end of supplementation, then 6, 9, and 12 months post end of AHCC supplementation.
Interventions
DIETARY_SUPPLEMENTAHCC 3 grams once a day
AHCC supplementation x 6 months with Placebo x 6 months
OTHERPlacebo
Placebo supplementation x 12 months
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blind, placebo control phase II study that patients receive either AHCC or placebo.
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* • Women over 30 years of age who have a HPV positive test and normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia within three months of study entry. * Women must have had 2 other HPV positive tests with normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia * 1 greater than 6 months and no more than 18 months prior to study entry * 1 greater than 24 months prior to study entry. * Women of child bearing potential must have a negative urine pregnancy test within 7 days of therapy start. * Patients must have adequate hematologic, renal, and hepatic function as noted from labs within the previous 12 months: ANC \>/= 1,500 cells/mm3, platelets 100,000 \>/= cells/mm3; Creatinine clearance\>/= 60 mL/min (estimated by Cockcroft Gault equation), total bilirubin, SGPT, SGOT, and alkaline phosphatase \</= 1.5 times normal. * Patients of child-bearing age must agree to use effective methods of contraception (oral contraceptives, condoms, etc.) while on study.
Exclusion criteria
* • History of myocardial infarction within past 6 months, unstable angina, CHF, or uncontrolled hypertension (\> 140/90). * Women with a current or prior diagnosis of cancer * Women with a current diagnosis of CIN3 cervical dysplasia * Women that are pregnant or breast feeding. * Women with a history of Hepatitis (autoimmune, A, B, or C) or antigen positive * Patients with history of significant psychiatric disorders (schizophrenia, bipolar, psychosis) or uncontrolled seizures. * Patients with significant medical co-morbidities at the discretion of the primary Gynecologist. Including immunosuppressive conditions (i.e. HIV+, rheumatoid arthritis, etc) or taking immune modulation mediations (i.e. immunosuppressants) * Women that have taken AHCC within the past six months. * Women currently taking other immune modulating nutritional supplements. * Patients who have undergone a hysterectomy (supracervical hysterectomy allowed)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Roche, COBAS HPV DNA Assay (Pleasanton, CA) | once every 3 months for 12 months up to 18 months | HPV DNA testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interferon beta | once every 3 months for 12 months up to 18 months | Evaluation of Interferon Beta level |
| Interferon gamma | once every 3 months for 12 months up to 18 months | Evaluation of Interferon gamma level |
| NK Cells | once every 3 months for 12 months up to 18 months | Evaluation of Natural Killer (NK) cells |
Countries
United States
Outcome results
None listed