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

NCT04911335 | Completed Phase 2

• 1 other identifier: 2021.82
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Palliative care; Hospice; Home palliative care; Oral assessment guide

Outcome Measures

Primary Outcomes (1)

• Severity of oral mucositis

  Reduction of the severity of mucositis by at least one degree, or maintenance of the normal condition, measured by the elements of the OAG scale whose score indicates 3 degrees (from 1 normal condition to 3 severe mucositis). The minimum grade achieved during the patient's stay in the study will be considered.

  daily up to 15 days

Secondary Outcomes (11)

• orpharyngeal pain

  daily up to 15 days

• esophageal pain

  daily up to 15 days

• dysgeusia

  daily up to 15 days

• ability to swallow, voice condition, feeling of dry mouth

  daily up to 15 days

• Oral fungal infections

  daily up to 15 days

Study Arms (1)

phase 2 open intervention

EXPERIMENTAL

All patients assisted by the palliative care center (hospice and home) will receive the oral hygiene protocol and the propolis-based product. The oral hygiene protocol will be applied starting from the day of taking care of the patient in the service and until discharge / death. Administration of the study product will be continued for 2 weeks or stopped sooner if the patient loses the ability to swallow.

Combination Product: Faringel plus and oral hygiene

Interventions

Faringel plus and oral hygiene COMBINATION_PRODUCT

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.

phase 2 open intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients cared for by specialized palliative care center in hospice or at home
• Conscious patients able to swallow (score 1-2 at the swallowing item of OAG)
• Patients with a life expectancy of between one week and one month estimated with the RAD (Approximation of Death Recognition) card in use in the palliative care center where the study will be conducted;
• Patients who provide consent to participate in the study and use the data independently, or through their legal representative.

You may not qualify if:

• Patients with a life expectancy of less than one week or more than one month estimated with the RAD (Approximation of Death Recognition) card;
• Patients who are unable to swallow (score 3 on the swallowing item on the OAG scale)
• Patients with head / neck cancer or tracheostomy;
• Patients who report allergy to propolis, honey, aloe, chamomile, calendula, stevia (or other components of the product under study) or atopy.

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Centro di cure palliative Insieme per la cura

Roma, RM, 00128, Italy

Location

Related Publications (5)

• 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.

  PMID: 30754984 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.

  PMID: 25832897 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.

  PMID: 28840622 BACKGROUND

• 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.

  PMID: 40197962 DERIVED

• 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.

  PMID: 39711194 DERIVED

MeSH Terms

Conditions

Stomatitis

Interventions

faringel; Oral Hygiene

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hygiene; Therapeutics; Preventive Dentistry; Dentistry

Study Officials

• Michela Piredda, Dr

  Campus BioMedico di Roma University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two-step design according to Simon's Optimum approach (1989). Overall sample = 77 evaluable cases (step1\_26 cases; step2\_51 cases). Parameters: P0 (minimum probability of response): 0.45; P1 (probability of optimal response): 0.60; Alpha: 5%; Power: 80%.

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 3, 2021
• Study Start: July 13, 2021
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the end of the study, and for 3 years after publication of results
• Access Criteria: Investigators registered on Clinical.trial.gov who require the data

Locations

IT (1)