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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2022-11-07

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Oral Mucositis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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phase 2 open intervention

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.

Group Type EXPERIMENTAL

Faringel plus and oral hygiene

Intervention Type 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.

Interventions

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Faringel plus and oral hygiene

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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No