Efficacy and Safety of Carboxymethyl Beta-glucan and Policarbophil in HPV Positive Patients

NCT06199128 | Completed

• 1 other identifier: The Fix Study V.2 12/Jul/2022
• Study Type: observational
• Target: 533
• Locations: 1 country
• Sites: 5

Brief Summary

Prospective, Controlled, Multicentre, Real Clinical Practice Study. Effectiveness of Carboxymethyl β-Glucan treatment in high-risk HPV+ patients

Conditions

Human Papillomavirus Infection

Keywords

HPV

Outcome Measures

Primary Outcomes (1)

• Evolution in the total or partial negativization of high-risk HPV infection in women with or without cytological alterations upon local treatment with carboxymethyl-β-glucan and polycarbophil.

  Evaluation of the total or partial negativization of HPV by HPV PCR test with genotype

  6 months

Secondary Outcomes (3)

• Normalization rate of abnormal colposcopy

  6 Months

• Change in the incidence of cytological alterations upon local treatment with carboxymethyl - β-glucan and polycarbophil during the follow-up time

  6 Months

• Determine the effect of local treatment with carboxymethyl - β-glucan and polycarbophil on the total negativization rate of HPV

  6 Months

Study Arms (2)

CONTROL GROUP

For the duration of the study, standard clinical practice will be followed wait and see strategy, without administering carboxymethyl-b-glucan treatment.

TREATMENT GROUP

For a period of three months, patients will be administered once daily treatment with Carboxymethyl β-glucan and Polycarbophil

Dietary Supplement: carboxymethyl β-glucan

Interventions

carboxymethyl β-glucan DIETARY_SUPPLEMENT

It is a vaginal spray gel designed for the prevention and treatment of cervical lesions caused by HPV. This is achieved by controlling the physiological conditions of the transformation zone of the cervico-vaginal mucosa. The composition of the gel, which includes polycarbophil and carboxymethyl-beta-glucan, effectively shields the cervico-vaginal mucosa from the damaging effects of external agents due to its bioadhesive capacity. Additionally, it contributes to the re-epithelialization and regression of cervical lesions

TREATMENT GROUP

Eligibility Criteria

• Age: 25 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The data will be collected from patients who meet the selection criteria.

You may qualify if:

• Women aged between 25 and 65 years (inclusive).
• Histological cervical cytology results reported as ASCUS, LSIL/CIN1, with a positive cervical PCR determination for high-risk HPV (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68).
• Patients currently undergoing treatment with the combination of carboxymethyl B-glucan and polycarboxyl (for at least 15 days prior to study initiation)
• Capable of reading and comprehending the patient information sheet and the informed consent form.
• Willing to participate in the study and sign the informed consent form.

You may not qualify if:

• Cervical cytology indicating suspected invasive cervical cancer.
• Ongoing or recent pregnancy terminated within six weeks of the study commencement.
• Clinically significant immunodeficiency-linked pathology.
• Active or terminated immunosuppressive treatment within six months of study entry. Specifically, in the case of corticosteroids, women will be excluded if they are currently or recently receiving corticosteroid treatment (defined as within two weeks prior to study entry) or if they have undergone two or more cycles of corticosteroids at doses equal to or greater than 20 mg/day of Prednisone (or equivalent) orally or parenterally for at least one week's duration in the year prior to study entry.
• Undiagnosed abnormal genital bleeding.
• Total hysterectomy.
• Documented history of cervical pathology caused by HPV.
• Contraindications to the use of the combination of Carboxymethyl B-glucan and polycarboxyl, or known allergies to any of its components.
• CONTROL GROUP
• Women aged between 25 and 65 years (inclusive).
• Histological cervical cytology results reported as ASCUS, LSIL/CIN1, with a positive cervical PCR determination for high-risk HPV (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68).
• Patients not currently undergoing treatment for HPV.
• Capable of reading and comprehending the patient information sheet and the informed consent form.
• Willing to participate in the study and sign the informed consent form.
• Cervical cytology indicating suspected invasive cervical cancer.

Sponsors & Collaborators

• Uriach Consumer Healthcare: lead

Study Sites (5)

Hospital CIMA, Barcelona

Barcelona, Spain

Location

Hospital Quirón San José

Madrid, 28002, Spain

Location

Hospital Universitario Infanta Leonor,

Madrid, 28031, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Quirón Donostia

San Sebastián, 20012, Spain

Location

Related Publications (6)

• Stentella P, Biamonti A, Carraro C, Inghirami P, Mancino P, Pietrangeli D, Votano S, Lazzari P, DE Medici C. Efficacy of carboxymethyl beta-glucan in cervical intraepithelial neoplasia: a retrospective, case-control study. Minerva Ginecol. 2017 Oct;69(5):425-430. doi: 10.23736/S0026-4784.17.04053-9.

  PMID: 28675291 BACKGROUND

• Chaichian S, Moazzami B, Sadoughi F, Haddad Kashani H, Zaroudi M, Asemi Z. Functional activities of beta-glucans in the prevention or treatment of cervical cancer. J Ovarian Res. 2020 Mar 5;13(1):24. doi: 10.1186/s13048-020-00626-7.

  PMID: 32138756 BACKGROUND

• Pietrantoni E, Signore F, Berardi G, Donadio F, Donadio C. [Role of beta-glucan in the treatment of recurrent candidiasis and HPV-correlated lesions and reparative process of epidermis]. Minerva Ginecol. 2010 Feb;62(1):1-5. Italian.

  PMID: 20186110 BACKGROUND

• Lavitola G, Della Corte L, De Rosa N, Nappi C, Bifulco G. Effects on Vaginal Microbiota Restoration and Cervical Epithelialization in Positive HPV Patients Undergoing Vaginal Treatment with Carboxy-Methyl-Beta-Glucan. Biomed Res Int. 2020 Apr 27;2020:5476389. doi: 10.1155/2020/5476389. eCollection 2020.

  PMID: 32420349 BACKGROUND

• Laccetta G, Carrone A, Burratti M, Mancino P. Effect of the treatment with beta-glucan in women with cervical cytologic report of atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (L-SIL). Minerva Ginecol. 2015 Apr;67(2):113-20. Epub 2015 Feb 5.

  PMID: 25668505 BACKGROUND

• Jentschke M, Lehmann R, Drews N, Hansel A, Schmitz M, Hillemanns P. Psychological distress in cervical cancer screening: results from a German online survey. Arch Gynecol Obstet. 2020 Sep;302(3):699-705. doi: 10.1007/s00404-020-05661-9. Epub 2020 Jun 27.

  PMID: 32594298 BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmen Pingarrón Santofima, Doctor

  Hospital Quirón San José

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 10, 2024
• Study Start: September 22, 2022
• Primary Completion: September 22, 2023
• Study Completion: November 22, 2023
• Last Updated: January 10, 2024

Record last verified: 2023-12

Locations

ES (5)