Carrageenan for the Prevention of Oral HPV Infection

Carrageenan for the Prevention of Oral HPV Infection: a Feasibility, Randomized Clinical Trial

This is a placebo-controlled, triple-blind randomized clinical trial (RCT) designed to evaluate the feasibility of conducting a larger multicentric RCT investigating the effect of a Carrageenan mouthwash on oral HPV infection. Eligible participants will complete a single in-person visit at baseline, filling out a questionnaire on their electronic device and giving an oral rinse sample for HPV testing. They will receive an adequate supply of mouthwash and instructions on its use. They will subsequently be followed up for up to six months. Every two weeks, participants will fill out a follow-up questionnaire on mouthwash use and sexual activities and self-collect oral rinse sample to be returned by mail.

Study Overview

• Status: Recruiting
• Conditions: Human Papilloma Virus
• Intervention / Treatment: Other: Mouthwash gargling

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Belinda Nicolau, DDS, PhD; Phone Number: 09465 1-514-398-7203; Email: belinda.nicolau@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G 1Y6
      • Recruiting
      • McGill University
      • Contact: Belinda Nicolau, PhD; Phone Number: 09465 1-514-398-7203; Email: belinda.nicolau@mcgill.ca
      • Contact: Babatunde Alli, BDS, MSc; Email: babatunde.alli@mcgill.ca
      • Principal Investigator: Belinda Nicolau, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged between 18 and 45 years old
• Sexually active and have had oral sex in the past month
• Will be residing in Montreal for the next six (6) months after study enrolment

Exclusion Criteria:

• Previous vaccination against HPV
• Previous cancer of the mouth or throat

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carrageenan-based Mouthwash; Mouthwash with Carrageenan as an active ingredient	Other: Mouthwash gargling; 15 - 20 ml of mouthwash to be gargled vigorously for 30 to 60 seconds daily (morning and night) as an adjunct to regular toothbrushing, and before and/or immediately after sexual activities.
Placebo Comparator: Placebo Mouthwash; Mouthwash without Carrageenan but similar in colour, taste, and "mouthfeel" to the experimental mouthwash	Other: Mouthwash gargling; 15 - 20 ml of mouthwash to be gargled vigorously for 30 to 60 seconds daily (morning and night) as an adjunct to regular toothbrushing, and before and/or immediately after sexual activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	This will be measured by the total number of participants recruited into the study. The investigators intend to recruit 40 participants. Recruitment rate will be calculated as number of participants per month.	1 year
Drop-out rate	The proportion of individuals who enrolled into the study but left before the end of the study will be documented.	1 year
Adherence rate for mouthwash use	This will be calculated as the proportion of participants who completed the study and complied with the mouthwash use regimen.	6 months
Adherence rate for self-sampling	This will be calculated as the proportion of participants who completed the study and complied with the bi-weekly self-sampling procedure	6 month
Acceptability of study procedures as assessed by satisfaction on a Visual Analog Scale	Qualitative and quantitative assessment will be used to evaluate participants' experience with the RCT through the follow-up questionnaire and an exit question. Participants will be asked to rate their satisfaction with the study procedure on a scale of 1-10 (10 being the highest satisfaction level). This will focus on level of satisfaction of the participants with mouthwash use around sexual activities and the level of satisfaction of the participants with the biweekly self-sampling.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mouthwash safety (Pain score) as assessed by the Visual Analog Scale	The mean pain score (for any pain ascribed to the mouthwash e.g., burning mouth, recurrent aphthous stomatitis e.t.c.) measured on the VAS (1-10; 10 being the worst pain) will be recorded.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to oral HPV infection	Time to type-specific oral HPV infection will be recorded for participants with negative type-specific oral HPV status at baseline	6 months
Time to oral HPV clearance	Time to type-specific oral HPV clearance will be recorded for participants with positive type-specific oral HPV status at baseline	6 months

Collaborators and Investigators

• Sponsor: McGill University
• Investigators: Principal Investigator: Belinda Nicolau, DDS, PhD, McGill University

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Mouthwash; Carrageenan; Oral HPV infection
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Neoplasms, Squamous Cell; Urogenital Diseases; Genital Diseases; Infections; Papillomavirus Infections; Papilloma
• Other Study ID Numbers: A03-M01-22A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No