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

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).

Timeline

Start

2021-07-13

Primary completion

2022-11-07

Completion

2022-11-07

Publications

• Background Magnani C, Mastroianni C, Giannarelli D, Stefanelli MC, Di Cienzo V, Valerioti T, Casale G. Oral Hygiene Care in Patients With Advanced Disease: An Essential Measure to Improve Oral Cavity Conditions and Symptom Management. Am J Hosp Palliat Care. 2019 Sep;36(9):815-819. doi: 10.1177/1049909119829411. Epub 2019 Feb 12.
• Background Mercadante S, Aielli F, Adile C, Ferrera P, Valle A, Fusco F, Caruselli A, Cartoni C, Massimo P, Masedu F, Valenti M, Porzio G. Prevalence of oral mucositis, dry mouth, and dysphagia in advanced cancer patients. Support Care Cancer. 2015 Nov;23(11):3249-55. doi: 10.1007/s00520-015-2720-y. Epub 2015 Apr 3.
• Background Piredda M, Facchinetti G, Biagioli V, Giannarelli D, Armento G, Tonini G, De Marinis MG. Propolis in the prevention of oral mucositis in breast cancer patients receiving adjuvant chemotherapy: A pilot randomised controlled trial. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12757. Epub 2017 Aug 25.
• Mastroianni C, Marchetti A, Sguanci M, Amato S, Giannarelli D, Casale G, Piredda M, De Marinis MG. Concordance of the World Health Organization, Oral Assessment Guide, and Tardieu Scales for Assessment of Oral Mucositis and Oral Disorders in Palliative Care Patients. J Palliat Med. 2025 Sep;28(9):1239-1245. doi: 10.1089/jpm.2024.0505. Epub 2025 Apr 8.
• Piredda M, Mastroianni C, Marchetti A, Sguanci M, Farinella R, Natale M, Giannarelli D, Monaco E, Martinato M, Armento G, Casale G, De Marinis MG. A Propolis-Based Protocol for Oral Health in Palliative Care: Results from a Phase II Trial. J Palliat Med. 2025 Feb;28(2):243-250. doi: 10.1089/jpm.2024.0290. Epub 2024 Dec 23.

Drugs

Indications