Clinical trial NCT04911335: Propolis-based Product (FARINGEL PLUS) for Oral Mucositis in Palliative Care
Official title: Sicurezza ed Efficacia di un Prodotto a Base di Propoli (FARINGEL PLUS) Nella Prevenzione e Nel Trattamento Della Mucosite Orale in Pazienti in Cure Palliative: Uno Studio di Fase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Mucositis
Keywords: Palliative care
Hospice
Home palliative care
Oral assessment guide
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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%.
Primary purpose: TREATMENT

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).

Detailed description: Palliative Care with has primary objective of the best possible quality of life for patients with advanced illness. Oral health is crucial for quality of life. Oral disorders such as hyposalivation, mucositis, erythema, ulceration and viral and fungal infections, can cause annoying symptoms such as dry mouth, dysphagia, dysgeusia, orofacial pain and speech difficulties, which negatively affect nutrition, verbal communication, social interaction and sleep. An Italian study of advanced cancer patients in palliative care found a prevalence of oral mucositis of 22%, of dysphagia of 15% and of dry mouth of 40%.

Studies on interventions aimed at preventing and treating oral mucositis in palliative care are scarse and no standard oral protocol can be recommended.

Moreover, there are no known scales specifically developed and validated for the evaluation of mucositis and other disorders of the oral cavity in palliative care.

Propolis has historically been used as folk medicine due to multiple biological properties, such as anesthetic, antimicrobial, antifungal, antiviral, and anti-inflammatory for the oral and pharyngeal mucosa. Propolis is effective in reducing the severity of radiation-induced oral mucositis in animals, is associated with a significant reduction in the number and size of oral ulcers in patients diagnosed with recurrent stomatitis and with complete recovery from denture-related stomatitis, and is found safe, acceptable and with promising efficacy in preventing oral mucositis in patients undergoing chemotherapy for breast cancer.

In particular, an oral suspension based on propolis (Faringel) and containing aloe vera gel, calendula, chamomile and sodium alginate, has been found to be well accepted, safe and promising in the prevention of severe oesophagitis from radiotherapy in patients with lung cancer. Hyaluronic acid (Faringel plus) has recently been added to this suspension with a re-epithelizing function on the mucous membranes.

Therefore, we planned this single-center, prospective, uncontrolled open label Phase 2 non-profit study aimed at evaluating whether the addition of a propolis-based product (FARINGEL PLUS) to a basic oral hygiene protocol can be safe, acceptable and active in the protection of the oral cavity in patients in palliative care.

To verify this hypothesis, a two-step design was adopted according to Simon's Optimum design approach. An overall sample of 77 evaluable cases was defined (step1_26 cases; step2_51 cases).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Severity of oral mucositis
timeFrame: daily up to 15 days
Secondary outcomes:
measure: orpharyngeal pain
timeFrame: daily up to 15 days
measure: esophageal pain
timeFrame: daily up to 15 days
measure: dysgeusia
timeFrame: daily up to 15 days
measure: ability to swallow, voice condition, feeling of dry mouth
timeFrame: daily up to 15 days
measure: Oral fungal infections
timeFrame: daily up to 15 days
measure: Duration of oral disorders
timeFrame: daily up to 15 days
measure: Comfort during feeding
timeFrame: daily up to 15 days
measure: Meal completion rate
timeFrame: daily up to 15 days
measure: Patient quality of life
timeFrame: Every 3 days up to 15 days
measure: Patient oral-related quality of life
timeFrame: Daily up to 15 days
measure: Adherence to intervention
timeFrame: daily up to 15 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Centro di cure palliative Insieme per la cura
state: RM
Study officials:
affiliation: Campus BioMedico di Roma University
name: Michela Piredda, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.