Use of quercetin ointment in the treatment of acute proctitis caused by radiotherapy in prostate cancer patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients. For randomization after registration of eligible patients, they are assigned to treatment groups (Quercetin and placebo) based on a random algorithm following the dynamic allocation procedure.
Settings and conduct
The study to evaluate the effectiveness of quercetin ointment on the complication of acute proctitis caused by radiotherapy in prostate cancer patients undergoing treatment in Shahid Rajaee hospital in babolsar and patients will be randomly divided into 2 groups. One group will be treated with placebo (as placebo) and the other group will be treated with Quercetin ointment, which are equalized in terms of color, shape, consistency and odor, and placebo and Quercetin ointment in the same and impossible dishes. In this study, patients and researchers were blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: prostate cancer patients undergoing radiotherapy with a field encompassing almost whole rectum
Exclusion criteria: Patients with history of previous radiotherapy of pelvis region ,Patients receiving treatment with anti-inflammatory drugs,Patients with acute or chronic pelvic infection
Intervention groups
Candidates will be randomly assigned to two groups. These patients receive either quercetin ointment (experimental group) or placebo (placebo group)
Main outcome variables
Radiotherapy induced proctitis based on the staging system of the Radiation Oncology Group (RTOG)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120707010205N10
Registration date:2022-09-19, 1401/06/28
Registration timing:registered_while_recruiting
Last update:2022-09-19, 1401/06/28
Update count:0
Registration date
2022-09-19, 1401/06/28
Registrant information
Name
Dariush Moslemi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1323 6752
Email address
d.moslemi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of quercetin ointment in the prevention of radiation-induced acute proctitis in prostate cancer patients
Public title
Evaluation of the effects of quercetin ointment in the prevention of radiation-induced acute proctitis in prostate cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
prostate cancer patients undergoing radiotherapy with a field encompassing almost whole rectum and receive a minimum dose of 4000 cGy radiation
Exclusion criteria:
Patients with history of previous radiotherapy of pelvis region
Patients receiving treatment with anti-inflammatory drugs (NSAIDS, corticosteroids)
Patients with inflammatory bowel disease (ulcerative colitis , Crohn's disease )
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, packages containing medicine or placebo are placed in the box as a mixture, and when offered to the candidates, without looking inside the box, one of the packages is randomly selected and given to the candidate. The package containing the placebo is marked with the letter A and the package containing the medicine is marked with the letter B.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, quercetin ointment and placebo are completely identical in terms of color, shape, consistency and smell, and are placed in the same containers so that the contents of the containers are not visible in terms of shape, color and consistency for the researcher and the patient. Somehow it is planned that neither the participant nor the researcher know which of the two control or test groups quercetin ointment or placebo is given.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganj afrooz street
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2022-03-06, 1400/12/15
Ethics committee reference number
IR.MUBABOL.HRI.REC.1400.246
Health conditions studied
1
Description of health condition studied
Radiation proctitis
ICD-10 code
K62.7
ICD-10 code description
Radiation proctitis
Primary outcomes
1
Description
score of acute proctitis according to the staging system of the Radiation Oncology Group (RTOG)
Timepoint
At the beginning of the study and then every week after the start of quercetin ointment consumption
Method of measurement
RTOG criteria to evaluate acute proctitis reaction induced by radiation therapy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: concurrent with beginning of radiotheray,every day 5 cc of prepared quercetin ointment will be used by enema twice ingredients of quercetin ointment: chitosan,quercetin 2%,Carboxymethyl cellulose and sodium alginate substances will be from Sigma-Aldrich brand and will be combined in pharmacology laborartory,clean room of Babol University of Medical Sciences
Category
Treatment - Drugs
2
Description
Control group: concurrent with beginning of radiotheray,every day 5 cc of prepared placebo ointment will be used by enema twice a day placebo ingredients: chitosan,Carboxymethyl cellulose, sodium alginate and edible food color (to make the combination look like quercetin ointment) substances will be from Sigma-Aldrich brand and will be combined in pharmacology laborartory,clean room of Babol University of Medical Sciences
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid rajaee hospital
Full name of responsible person
Dariush Moslemi
Street address
Shariati street
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3528 9259
Email
info@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Reza Ghadimi
Street address
Ganj afrooz street
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 9123 2959
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr Dariush Moslemi
Position
Lecturer/Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Department of Radiation Oncology, Babol University of Medical Sciences,
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 1223 4143
Fax
Email
moslemi_d@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Dariush Moslemi
Position
Lecturer/Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Department of Radiation Oncology, Babol University of Medical Sciences,
City
Babol,
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 1223 4143
Fax
Email
moslemi_d@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dariush Moslemi
Position
Assistant professor of radiation oncology
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Devision of radiation oncology, Babol University of Medical Sciences, ganj afrooz street, babol, mazandaran, iran
City
Babol
Province
Mazandaran
Postal code
4717447745
Phone
+98 11 1222 4032
Fax
+98 11 1223 4367
Email
moslemi_d@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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