Clinical trial NCT06199128: Efficacy and Safety of Carboxymethyl Beta-glucan and Policarbophil in HPV Positive Patients
Official title: Evaluation of the Efficacy and Safety of the Local Treatment of Carboxymethyl Beta-glucan and Polycarbophil in Patients With Normal Cytology/ASCUS/LSIL (CIN1) With HPV+ PCR Determination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Infection
Keywords: HPV
Lead sponsor: Uriach Consumer Healthcare
Sponsor class: INDUSTRY
First posted: 2024-01-10
Enrollment: 533
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The data will be collected from patients who meet the selection criteria.

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

Detailed description: To evaluate the effectiveness of local treatment with carboxymethyl-b-glucan and polycarbophil on the clearance time of human papillomavirus (HPV), as well as on the normalisation of cytological alterations identified at study inclusion.

Eligibility criteria: TREATMENT GROUP

INCLUSION:

* 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.

EXCLUSION:

* 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

INCLUSION:

* 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.

EXCLUSION:

* 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.
* Concurrent participation in a clinical study of an investigational drug that could interfere with the current study.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Normalization rate of abnormal colposcopy
timeFrame: 6 Months
measure: Change in the incidence of cytological alterations upon local treatment with carboxymethyl - β-glucan and polycarbophil during the follow-up time
timeFrame: 6 Months
measure: Determine the effect of local treatment with carboxymethyl - β-glucan and polycarbophil on the total negativization rate of HPV
timeFrame: 6 Months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital CIMA, Barcelona
city: Madrid
country: Spain
facility: Hospital Quirón San José
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor,
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: San Sebastián
country: Spain
facility: Hospital Quirón Donostia
Study officials:
affiliation: Hospital Quirón San José
name: Carmen Pingarrón Santofima, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.