Propolis-based Product (FARINGEL PLUS) for Oral Mucositis in Palliative Care (FARINGEL-CP)
Primary Purpose
Oral Mucositis
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Faringel plus and oral hygiene
Sponsored by
![Campus Bio-Medico University](https://trials-media.s3.amazonaws.com/orgs/campus-bio-medico-university.jpeg)
About this trial
This is an interventional treatment trial for Oral Mucositis focused on measuring Palliative care, Hospice, Home palliative care, Oral assessment guide
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.
Sites / Locations
- Centro di cure palliative Insieme per la cura
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
phase 2 open intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
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).
Oral fungal infections
Presence and severity of fungal infections measured with CTC-AE (grade 0-5)
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;
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)
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
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)
Patient oral-related quality of life
Oral-related quality of life measured with the Oral Mucositis Daily Questionnaire (OMDQ)
Adherence to intervention
Adherence to oral care and to administration of the product under study recorded daily as frequency, type and quantity
Full Information
NCT ID
NCT04911335
First Posted
May 24, 2021
Last Updated
February 7, 2023
Sponsor
Campus Bio-Medico University
1. Study Identification
Unique Protocol Identification Number
NCT04911335
Brief Title
Propolis-based Product (FARINGEL PLUS) for Oral Mucositis in Palliative Care
Acronym
FARINGEL-CP
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
November 7, 2022 (Actual)
Study Completion Date
November 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Palliative care, Hospice, Home palliative care, Oral assessment guide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
phase 2 open intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Faringel plus and oral hygiene
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severity of oral mucositis
Description
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.
Time Frame
daily up to 15 days
Secondary Outcome Measure Information:
Title
orpharyngeal pain
Description
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
Time Frame
daily up to 15 days
Title
esophageal pain
Description
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
Time Frame
daily up to 15 days
Title
dysgeusia
Description
Dysgeusia assessed with a Numerical Rating Scale (NRS), from 0 to 10 meaning 0 the absence of symptom and 10 the worst symptom imaginable
Time Frame
daily up to 15 days
Title
ability to swallow, voice condition, feeling of dry mouth
Description
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).
Time Frame
daily up to 15 days
Title
Oral fungal infections
Description
Presence and severity of fungal infections measured with CTC-AE (grade 0-5)
Time Frame
daily up to 15 days
Title
Duration of oral disorders
Description
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;
Time Frame
daily up to 15 days
Title
Comfort during feeding
Description
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)
Time Frame
daily up to 15 days
Title
Meal completion rate
Description
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
Time Frame
daily up to 15 days
Title
Patient quality of life
Description
Quality of life measured at time 0 and then every 3 days with the European Quality of Life Utility Scale (EQ-5D)
Time Frame
Every 3 days up to 15 days
Title
Patient oral-related quality of life
Description
Oral-related quality of life measured with the Oral Mucositis Daily Questionnaire (OMDQ)
Time Frame
Daily up to 15 days
Title
Adherence to intervention
Description
Adherence to oral care and to administration of the product under study recorded daily as frequency, type and quantity
Time Frame
daily up to 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michela Piredda, Dr
Organizational Affiliation
Campus BioMedico di Roma University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro di cure palliative Insieme per la cura
City
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share all the IPD that undely a publication, after the end of the study
IPD Sharing Time Frame
After the end of the study, and for 3 years after publication of results
IPD Sharing Access Criteria
Investigators registered on Clinical.trial.gov who require the data
Citations:
PubMed Identifier
30754984
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.
Results Reference
background
PubMed Identifier
25832897
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.
Results Reference
background
PubMed Identifier
28840622
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.
Results Reference
background
Learn more about this trial
Propolis-based Product (FARINGEL PLUS) for Oral Mucositis in Palliative Care
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