Determining the effect of Aloe vera on the prevention and treatment of mucositis caused by head and neck radiotherapy
Design
Clinical trial with control group, with parallel groups, double-blind, random phase 2-3, 80 patients divided into 2 groups using randomized permutation block method and 40 people receive aloe vera and 40 people receive placebo
Settings and conduct
The study is performed in Isfahan and on those who refer to Seyed Al-Shohada Hospital. Blinding is done with the same drug and placebo packaging and coding.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age newly diagnosed with head and neck cancers without previous history of radiotherapy and Karnovsky over 70
Intervention groups
The control group is given mouthwash containing Aloe vera and the control group is given a placebo with a similar appearance during the treatment period
Main outcome variables
The frequency distribution of mucosal symptoms varies from week to week in each patient receiving aloe vera and placebo.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201203049585N1
Registration date:2021-02-11, 1399/11/23
Registration timing:prospective
Last update:2021-02-11, 1399/11/23
Update count:0
Registration date
2021-02-11, 1399/11/23
Registrant information
Name
Nadia Najafizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3775 2366
Email address
nadianajafizade@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-23, 1399/12/05
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effects of Aloe vera on prevention and treatment of radiotherapy induced mucositis- Isfahan 2021
Public title
Effects of Aloe Vera on mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Indication of Head and Neck radiotherapy
Lack of previous history of radiation
Lack of any mucusitis due to radiation or any other couses
Lack of evidence of distant metastasis
Karnofsky Performance Status at least 70
Not to use of NSAID or Steroids or other analgesics
Absence of pregnancy
At least 50 gray of radiation dose
Exclusion criteria:
Patient request to exit
Patient die due to another reason
Severe adverse effects
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the clinical caregiver who provides the medication and placebo and the researcher who enters the data into the checklist will be unaware of which group each patient is in. The drug and the placebo will be sidelined with the same appearance and packaging.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8184917911
Approval date
2021-01-22, 1399/11/03
Ethics committee reference number
IR.MUI.MED.REC.139.973
Health conditions studied
1
Description of health condition studied
Head and Neck cancers
ICD-10 code
K12.33
ICD-10 code description
Oral mucositis (ulcerative) due to radiation
Primary outcomes
1
Description
RTOG grading of mucusitis
Timepoint
Record of RTOG grade before and every week of treatment and end of radiation
Method of measurement
RTOG grading questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: from the beginning of radiotherapy to the end of treatment, which lasts for an average of 6 weeks for each patient, patients are advised to gargle 5 cc of the received solution for 3 minutes 3 times a day. On the day of treatment, each patient is instructed on how to take the medicine and the empty medicine bottle is delivered and filled every two weeks according to the recommended dose. The aloe vera solution will contain pure aloe vera gel plus two-tenths of a percent methyl paraben and two-hundredths of a percent propyl paraben as a preservative.
Category
Treatment - Drugs
2
Description
Control group: they receive a placebo-containing bottle with the same appearance as the medicine in the same way.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed al-shohada hospital
Full name of responsible person
Roya mobini
Street address
Seyed al-shohada hospital, Motahari street
City
Isfahan
Province
Isfehan
Postal code
8184917911
Phone
+98 31 3236 0174
Email
Roya.mobini@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
sfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3673 0416
Email
Haghjoo@med.Mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Roya Mobini
Position
Physician
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Seyed al-shohada hospital, Shiri bridge, Motahari street
City
Esfahan
Province
Isfehan
Postal code
8184917911
Phone
+98 31 3775 2366
Fax
Email
Roya.mobini@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nadia Najafizade
Position
Physician
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Seyed al-shohada hospital, Shiri bridge, Motahari street
City
Esfahan
Province
Isfehan
Postal code
8184917911
Phone
+98 31 3775 2366
Fax
Email
Nadianajafizade@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Roya Mobini
Position
Physician
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Seyed al-shohada hospital, Shiri bridge, Motahari street
City
Esfahan
Province
Isfehan
Postal code
8184917911
Phone
+98 31 3775 2366
Fax
Email
Roya.mobini@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
Yes - There is 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
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
6 month after publishing
To whom data/document is available
Researchers working in academic and scientific institutions