Efficacy of an oral topical pomegranate peel (Punica granatum) product in prevention of acute radiation-induced oral mucositis in patients with head and neck cancer: A pilot study
Evaluation of efficacy of an oral topical pomegranate peel (Punica granatum) product in prevention of acute radiation-induced oral mucositis in patients with head and neck cancer
Design
A clinical trial with a control group, parallel groups, double-blind, and randomized.
Settings and conduct
Sixteen volunteer patients with head and neck cancer, aged between 18 and 75 years, referred to Shahid Tajrish Hospital (Tehran), who are about to start radiotherapy, will be enrolled in the study based on the inclusion and exclusion criteria and will be randomly assigned into two groups. The first group will receive the oral topical pomegranate peel product (intervention group), and the second group will receive a placebo (control group). Patient recruitment will continue until the sample size is complete in both groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Diagnosis of head and neck cancers based on pathology.
Candidate for radiotherapy of head and neck regions.
Presence of at least two areas showing mucositis (based on mucositis assessment criteria) within the radiotherapy field.
Age between 18 and 75 years.
Exclusion Criteria:
History of allergy to pomegranate.
Presence of infectious and recurrent oral lesions.
Dental diseases.
Use of alcohol or medications affecting salivary glands, such as antidepressants and opioids.
Liver and kidney diseases.
Diabetes.
Diseases causing dehydration, such as chronic diarrhea.
Intervention groups
The intervention and control groups will use, respectively, the oral spray containing pomegranate peel extract and the placebo product every four hours, six puffs each time, starting one day before the initiation of radiotherapy and continuing until two weeks after its completion or until the patient withdraws from the study for any reason.
Main outcome variables
Mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240607062030N1
Registration date:2025-04-24, 1404/02/04
Registration timing:prospective
Last update:2025-04-24, 1404/02/04
Update count:0
Registration date
2025-04-24, 1404/02/04
Registrant information
Name
Maryam Jahandideh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 0052
Email address
drjahandideh@iaups.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2025-05-05, 1404/02/15
Expected recruitment end date
2025-11-06, 1404/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of an oral topical pomegranate peel (Punica granatum) product in prevention of acute radiation-induced oral mucositis in patients with head and neck cancer: A pilot study
Public title
Effects of a pomegranate peel oral products on the prevention of oral mucositis induced by radiation therapy in head and neck cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with head and neck cancer based on pathology
Candidate for head and neck radiotherapy
The presence of at least two examined areas for mucositis (based on the mucositis assessment criteria) within the radiotherapy field
Age between 18 and 75 years
Exclusion criteria:
History of allergy to pomegranate
Presence of recurrent or infectious oral lesions
Presence of dental diseases
Liver and kidney diseases.
Use of alcohol or medications affecting the salivary glands, such as antidepressants and opioids.
Diagnosis of diabetes
Diseases causing dehydration, such as chronic diarrhea
History of connective tissue diseases such as Sjögren's syndrome, rheumatoid arthritis, and lupus.
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign individuals into two groups of 10, we first number them from 1 to 20 and then use SAS 9.1 software to randomly allocate them into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The pomegranate peel product and the placebo are placed in identical bottles in terms of appearance, and neither the researcher nor the patients are aware of their contents.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Department of Pharmaceutical Sciences,Tehran Islamic Azad University of Medical
Street address
Islamic Azad University of Pharmaceutical Sciences Branch., Yakhchal Ave., Dr Shariati Ave., Gholhak
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2024-01-06, 1402/10/16
Ethics committee reference number
IR.IAU.PS.REC.1402.555
Health conditions studied
1
Description of health condition studied
Radiation-induced oral mucositis
ICD-10 code
K12.33
ICD-10 code description
Oral mucositis (ulcerative) due to radiation
Primary outcomes
1
Description
Mucositis
Timepoint
Before intervention and the first to fifth weeks of radiotherapy and two weeks thereafter
Method of measurement
Clinical examination of seven areas of the oral cavity, questioning the patient using the VAS (Visual Analogue Scale).
Secondary outcomes
empty
Intervention groups
1
Description
Invention group: The oral spray containing pomegranate peel extract will be used every four hours, six puffs each time, starting one day before the initiation of radiotherapy and continuing until two weeks after its completion or until the patient withdraws from the study for any reason.
Category
Prevention
2
Description
Control group: The placebo oral spray will be used every four hours, six puffs each time, starting one day before the initiation of radiotherapy and continuing until two weeks after its completion or until the patient withdraws from the study for any reason.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Dr. Ghazaleh Heydarirad
Street address
Shahrdari Street,Tajrish Sqr, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
pr-shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Amirhossein Abdolghaffari
Street address
Islamic Azad University of Pharmaceutical Sciences Branch., Yakhchal Ave., Dr Shariati Ave., Gholhak.,
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Email
amirhosein172@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reza sayari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Islamic Azad University of Pharmaceutical Sciences Branch., Yakhchal Ave., Dr Shariati Ave., Gholhak.,
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Email
rezasayari06@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ghazaleh Heydarirad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Street, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6027
Email
dr.ghazalrad@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reza sayari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Islamic Azad University of Pharmaceutical Sciences Branch., Yakhchal Ave., Dr Shariati Ave., Gholhak.,
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Email
rezasayari06@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available