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NCT04911335: FARINGEL-CP

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

Completed Phase 2 Last updated 8 February 2023
What this trial tests

Phase 2 trial testing Faringel plus and oral hygiene in Oral Mucositis in 77 participants. Completed in 7 November 2022.

Timeline
13 July 2021
Primary endpoint
7 November 2022
7 November 2022

Quick facts

Lead sponsorCampus Bio-Medico University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment77
Start date13 July 2021
Primary completion7 November 2022
Estimated completion7 November 2022
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Campus Bio-Medico University

Who can join

18 and older, any sex, with Oral Mucositis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Concordance of the World Health Organization, Oral Assessment Guide, and Tardieu Scales for Assessment of Oral Mucositis and Oral Disorders in Palliative Care Patients.
    Mastroianni C, Marchetti A, Sguanci M, Amato S, et al · · 2025 · PMID 40197962 · DOI 10.1089/jpm.2024.0505
  2. A Propolis-Based Protocol for Oral Health in Palliative Care: Results from a Phase II Trial.
    Piredda M, Mastroianni C, Marchetti A, Sguanci M, et al · · 2025 · PMID 39711194 · DOI 10.1089/jpm.2024.0290

Verify or expand the search:

Other recruiting trials for Oral Mucositis

Currently open trials in the same condition.

Other Campus Bio-Medico University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04911335.

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