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Propolis-based Product (FARINGEL PLUS) for Oral Mucositis in Palliative Care

NCT04911335 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2023-02-08

No results posted yet for this study

Summary

Oral health is crucial for palliative patients' quality of life. The evidence on effective interventions and measures of oral mucositis in palliative care is sparse.

This is a single-center, prospective, uncontrolled open label Phase 2 non-profit study, aimed at evaluating a propolis-based product (FARINGEL PLUS) added to basic oral hygiene safety, acceptability and activity in preventing and treating oral mucositis in patients in palliative care.

A two-step design was adopted according to Simon's Optimum approach, with an overall sample of 77 evaluable cases (step1\_26 cases; step2\_51 cases).

Conditions

  • Oral Mucositis

Interventions

COMBINATION_PRODUCT

Faringel plus and oral hygiene

The expected frequency of administration of the study product is 2 / day, 10 minutes 'before main meals, for patients without mucositis (grade 1 according to the OAG scale, total score = 8). The frequency of administration will increase to 3 / day for patients with mild or moderate mucositis (grade 2 on the OAG scale, total score 9-18) and up to 4 / day in cases of severe mucositis (grade 3 on the OAG scale, score total 19-24). Each administration will contain 7 ml of oral suspension, to be kept inside the oral cavity for 1-2 minutes and then swallowed slowly.

Sponsors & Collaborators

  • Campus Bio-Medico University

    lead OTHER

Principal Investigators

  • Michela Piredda, Dr · Campus BioMedico di Roma University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-13
Primary Completion
2022-11-07
Completion
2022-11-07

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04911335 on ClinicalTrials.gov