We evaluate the clinical effects of pomegranate syrup to prevent complications of mucositis caused by radiotherapy.
Design
A controlled, parallel-group, double-blind, randomized, phase two clinical trial on 120 patients. The rand function of Excel software is used for randomization
Settings and conduct
The place of the cancer institute is Imam Khomeini Hospital in Tehran. Patients do not have information about the type of syrup received. Also, the researcher does not have information about the type of syrup received by the patient. The pharmacist delivers the medicine to the patient. The shape of the drug and placebo are similar, and pharmacists know about the type of syrup based on the code
Participants/Inclusion and exclusion criteria
Candidates for at least 50 Gy radiotherapy to the oral cavity with or without concurrent chemotherapy will be included in the study. Also, patients who had a history of head and neck radiotherapy, opium addiction or methadone use, active mucosal disease in the radiotherapy area and people under 18 years of age are excluded from the study.
Intervention groups
The first group is the control group, which includes 60 patients who receive placebo in the amount of 10 cc 3 times a day.
The second group, the intervention group, includes 60 patients who receive pomegranate flower mouthwash in the amount of 10 cc 3 times a day.
Investigating the effect of pomegranate flower syrup in preventing severe mucositis caused by radiotherapy after head and neck cancer surgery
Public title
Effect of pomegranate flower syrup in preventing mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The study of patients with head and neck cancers who are candidates for at least 50 Gy radiotherapy to the oral cavity with or without concurrent chemotherapy after surgery will be included in the study.
Exclusion criteria:
Patients who had a history of head and neck radiotherapy, opium addiction or methadone use, active mucosal disease in the radiotherapy area and people under 18 years of age are excluded from the study.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Using coded boxes with a random sequence
In this method, a number of boxes or cans that are numbered based on a random sequence are used. In these boxes, drugs or sheets with random allocation are used. If researchers use this method, they should make sure that the boxes are sealed enough, their appearance is similar, and their weight is the same. In this study, the drug container and the placebo have a clear similarity, and neither the researcher nor the patient knows about it.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient does not know about the type of syrup received
The researcher also has no information about the type of syrup received by the patient
The pharmacist only knows about the syrup received by the patients and delivers the medicine to the patients
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tehran University of Medical Sciences
Street address
Central Building of Tehran University of Medical Sciences, Intersection of Quds St, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2022-08-30, 1401/06/08
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.165
Health conditions studied
1
Description of health condition studied
Mucositis caused by radiotherapy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of mucositis according to who definition.
Timepoint
Checking the severity of mucositis every week during radiotherapy
Method of measurement
Based on the definition of the severity of mucositis of the World Health Organization. Severity of mucositis based on who definition. Zero grade: The patient has no symptoms. Grade 1: Erythema and mouth burning (brief mucosal inflammation) Grade 2: Erythema and oral ulcers that still have the ability to eat solid foods. (Mild pain that requires painkillers.) Grade 3: Ulcers with extensive erythema who cannot swallow solid food. (Severe pain that requires strong pain relief) Grade 4: Mucositis has become very widespread and has made feeding completely impossible for the person, and at the same time that there is a need for hospitalization for him.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Including 60 patients who receive pomegranate flower mouthwash in the amount of 10 cc 3 times a day. To prepare the product, firstly, pomegranate flower is procured from the medicinal plant market of Iran and a herbarium code is assigned to it by a botanist. To prepare 240 cc of pomegranate flower syrup, dissolve 8 grams of hydroalcoholic extract (70 degrees) prepared by maceration method and dried by rotary machine and vacuum in some distilled water, then add xylitol (sweetener) and methyl paraben (preservative). We add the volume of the solution with distilled water. We increase the pH of the placebo syrup to 240 cc. Finally, if needed, the viscosity-increasing and regulating agent isylitol is made as a sweetener and methyl paraben as a preservative, and the food coloring is used to match its color with pomegranate flower syrup. Standardization of syrup is done by determining the amount of total phenolic compounds through Folin Cicalto test, and gallic acid is used as a standard. The microbial control of the syrup is also done to ensure that the count of microorganisms is within the permissible limits of the pharmacopoeia. Patients undergo weekly visits from the first day of treatment to the end of radiotherapy for a total of 6-7 weeks.
Category
Treatment - Drugs
2
Description
Control group: 60 patients who receive placebo in the amount of 10 cc 3 times a day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute,Tehran Imam Khomeini Hospital
Full name of responsible person
Fatemeh samadi
Street address
Cancer Institute, Imam Khomeini Hospital, Qarib Ave.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2585
Email
dr.fatemeh.samadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr reza ghalethaki
Street address
Cancer Institute, Imam Khomeini Hospital, Gharib Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2585
Email
rezaght@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
fatemeh samadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Cancer Institute, Imam Khomeini Hospital, Gharib Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2585
Email
dr.fatemeh.samadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Samadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Cancer Institute, Imam Khomeini Hospital, Gharib AVe
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2585
Email
dr.fatemeh.samadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
fatemeh samadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Cancer Institute, Imam Khomeini Hospital, Gharib AVe
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
0098216192585
Email
dr.fatemeh.samadi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
The published information is related to the effect of pomegranate flower syrup in preventing mucositis and its effect on patient nutrition and weight gain
When the data will become available and for how long
The access period is expected to start from 1404
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
After completing the research, the data can be used for non-employees in the institutions as well.
From where data/document is obtainable
Email the following address to receive information and documents
dr.fatemeh.samadi@gmail.com
What processes are involved for a request to access data/document
After the completion of the research and data analysis, and considering that the patient is admitted until the end of 1403, the second six months of 1404, information and files can be accessed.