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NCT04911335: FARINGEL-CP
Propolis-based Product (FARINGEL PLUS) for Oral Mucositis in Palliative Care
Phase 2 trial testing Faringel plus and oral hygiene in Oral Mucositis in 77 participants. Completed in 7 November 2022.
7 November 2022
Quick facts
| Lead sponsor | Campus Bio-Medico University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 77 |
| Start date | 13 July 2021 |
| Primary completion | 7 November 2022 |
| Estimated completion | 7 November 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Faringel plus and oral hygiene
Conditions studied
- Oral Mucositis — all drugs for Oral Mucositis →
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):
-
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 -
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:
- PubMed search for NCT04911335
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Oral Mucositis
Currently open trials in the same condition.
- NCT07491536 — Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis · NA · recruiting
- NCT07400328 — Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients · Phase 2 · recruiting
- NCT06525402 — Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemothe · NA · recruiting
- NCT06315855 — F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors) · NA · recruiting
- NCT05966194 — RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer · Phase 2 · recruiting
Other Campus Bio-Medico University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04911335 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Campus Bio-Medico University
- Last refreshed: 8 February 2023
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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