Oral MucositisPhase 2FARINGEL-CPNCT04911335

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

A Phase 2 study testing Faringel plus and oral hygiene in people with Oral Mucositis, run by Campus Bio-Medico University at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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)… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Oral Mucositis
What is being tested?: Faringel plus and oral hygiene
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 1 siteItaly
Study dates: 13 Jul 2021to 7 Nov 2022
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Centro di cure palliative Insieme per la cura
Roma, RM, 00128

Other trials in Italy

About this study

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

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).

Read the 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).

Conditions: Oral Mucositis
Being tested: Faringel plus and oral hygiene
Keywords: Palliative care, Hospice, Home palliative care, Oral assessment guide
Medical subject headings: Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Faringel plus and oral hygieneCombination 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.

Study groups in NCT04911335
Study group	Role	What they receive
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. Receives: Combination Product: Faringel plus and oral hygiene

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: daily up to 15 days

Secondary outcomes (11)

orpharyngeal pain
Appearance and severity of oropharyngeal pain assessed with a Numerical Rating Scale (NRS), from 0 to 10 meaning 0 the absence of pain and 10 the worst pain imaginable
Measured: daily up to 15 days
esophageal pain
Appearance and severity of esophageal pain assessed with a Numerical Rating Scale (NRS), from 0 to 10 meaning 0 the absence of pain and 10 the worst pain imaginable
Measured: daily up to 15 days
dysgeusia
Dysgeusia assessed with a Numerical Rating Scale (NRS), from 0 to 10 meaning 0 the absence of symptom and 10 the worst symptom imaginable
Measured: daily up to 15 days
ability to swallow, voice condition, feeling of dry mouth
ability to swallow, voice condition, feeling of dry mouth assessed through the Oral Assessment Guide (OAG - Eilers 1988; D'Angelo et al., 2013) at 3 levels of severity (from 1 normal condition, 2 mild disorders / moderate, 3 severe disorders) and the Tardieu scale, at 4 levels of severity, where 0 is normal and 3 is the maximum degree of alteration).
Measured: daily up to 15 days
Oral fungal infections
Presence and severity of fungal infections measured with CTC-AE (grade 0-5)
Measured: daily up to 15 days
Duration of oral disorders
Duration of oral cavity disorders measured in days and defined from the moment in which a degree different from normality occurs until the first evaluation with return to normality;
Measured: daily up to 15 days
Comfort during feeding
Alteration of comfort during feeding measured daily with a Numerical Rating Scale (NRS), from 0 to 10 (0 complete absence of comfort and 10 maximum comfort)
Measured: daily up to 15 days
Meal completion rate
Food pattern compared to that of the 3 previous days and to the normal situation, measured in number of meals per day and average percentage of completion of individual meals
Measured: daily up to 15 days
Patient quality of life
Quality of life measured at time 0 and then every 3 days with the European Quality of Life Utility Scale (EQ-5D)
Measured: Every 3 days up to 15 days
Patient oral-related quality of life
Oral-related quality of life measured with the Oral Mucositis Daily Questionnaire (OMDQ)
Measured: Daily up to 15 days
Adherence to intervention
Adherence to oral care and to administration of the product under study recorded daily as frequency, type and quantity
Measured: daily up to 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 20217 Nov 2022

First posted3 Jun 2021
Study start13 Jul 2021
Primary completion7 Nov 2022
Study completion7 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Oral MucositisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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%.
Masking: None (open label)
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04911335
Sponsor's protocol ID: 2021.82
Acronym: FARINGEL-CP
Status last verified: Feb 2023
First submitted: 24 May 2021
Last updated: 8 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We plan to share all the IPD that undely a publication, after the end of the study

Publications

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.
PubMed 30754984
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.
PubMed 25832897
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.
PubMed 28840622
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.
PubMed 40197962
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.
PubMed 39711194

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Oral Mucositis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04911335
Acronym / sponsor ID: FARINGEL-CP / 2021.82
Conditions: Oral Mucositis
Keywords: Palliative care, Hospice, Home palliative care, Oral assessment guide
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Campus Bio-Medico UniversityUniversity, hospital or other
Study start: 13 Jul 2021 (actual)
Primary completion: 7 Nov 2022 (actual)
Study completion: 7 Nov 2022 (actual)
First posted: 3 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

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.

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).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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%.

Arm	Type	Receives
phase 2 open intervention	Experimental	Combination Product: Faringel plus and oral hygieneAll 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Faringel plus and oral hygieneThe 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.	Combination product	phase 2 open intervention

Primary outcome

Severity of oral mucositis
Time frame: daily up to 15 days
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.

11 secondary outcomes

orpharyngeal pain
Time frame: daily up to 15 days
esophageal pain
Time frame: daily up to 15 days
dysgeusia
Time frame: daily up to 15 days
ability to swallow, voice condition, feeling of dry mouth
Time frame: daily up to 15 days
Oral fungal infections
Time frame: daily up to 15 days
Duration of oral disorders
Time frame: daily up to 15 days
Comfort during feeding
Time frame: daily up to 15 days
Meal completion rate
Time frame: daily up to 15 days
Patient quality of life
Time frame: Every 3 days up to 15 days
Patient oral-related quality of life
Time frame: Daily up to 15 days
Adherence to intervention
Time frame: daily up to 15 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Background: PubMed 30754984Magnani 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: PubMed 25832897Mercadante 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: PubMed 28840622Piredda 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.
Derived from this study: PubMed 40197962Mastroianni 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.
Derived from this study: PubMed 39711194Piredda 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.
Individual participant dataSharing planned: Yes. We plan to share all the IPD that undely a publication, after the end of the study

Related trials for Oral Mucositis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michela Piredda, Dr principal investigator

Campus BioMedico di Roma University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Faringel plus and oral hygiene in people with Oral Mucositis, run by Campus Bio-Medico University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of oral mucositis (time frame: daily up to 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04911335, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.