Comparison of the effects of the Effects of Aloe Vera and Placebo Ointment in the Prevention of Radiation-Induced Acute Proctitis in Prostate Cancer Patients
Determination of efficacy of Aloe vera ointment in the prevention of radiation-induced acute proctitis in patients with prostate cancer
Design
Randomized parallel groups randomizes double blind clinical trial. The sample size will be 56 cases (28 in each group).
Settings and conduct
This clinical trial will be conducted on patients over 18 years of age with prostate cancer at Babolsar Shahid Rajaei Hospital. Patients will be randomized to receive Aloe vera or placebo and the effect of Aloe vera ointment 3 % will be compared with placebo. Physician and patients will be blind regarding the grouping of the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Signing of informed consent form; Age over 18 years old; Patients with prostate cancer undergoing pelvic radiation
Exclusion Criteria: Evidence of active infection; evidence of other sources of hematochezia including colon cancer; inflammatory bowel disease and hemorrhoids; anal incontinence; anorectal fistula; anorectal stenosis; previous rectal surgery; known allergy to any ingredients of the ointments; concomitant use of antibiotics or steroids.
Intervention groups
Intervention groups included aloe vera ointment group and control group receiving aloe vera placebo.
Main outcome variables
Developement of proctitis based on clinical presentation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090613002027N17
Registration date:2019-09-28, 1398/07/06
Registration timing:registered_while_recruiting
Last update:2019-09-28, 1398/07/06
Update count:0
Registration date
2019-09-28, 1398/07/06
Registrant information
Name
Ebrahim Salehifar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1311 6546
Email address
esalehifar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of the Effects of Aloe Vera and Placebo Ointment in the Prevention of Radiation-Induced Acute Proctitis in Prostate Cancer Patients
Public title
Evaluation of the effects of Aloe Vera Ointment in the radiation induced Proctitis in prostate cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being over 18 years old
Prostate cancer patients whom are under pelvic Radiotherapy
Exclusion criteria:
Evidence of active infection
Evidence suggesting other causes of bloody diarrhea, such as colon cancer, inflammatory bowel disease and hemorrhoids
Fecal Incontinence
Anorectal fistula
Anal Stenosis
History of surgery in the rectum area
Any known Sensitivity of the components used in the ointment
Concomitant use of antibiotics, Glucocorticoids and Sulfonamide compounds
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized according to block randomization with 4 cases in each block. For concealment, a 5 digits unique code will be obtained from Excel.
Blinding (investigator's opinion)
Double blinded
Blinding description
Aloe vera and placebo will be filled in identical containers, and the senior researcher will insert the unique code of each participant on the containers. The researcher and patient will not be aware of the type of intervention received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical sciences
Street address
Mazandaran University of Medical Scienses, kilometer 18 of Farah Abad road, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
861-48175
Approval date
2019-01-02, 1397/10/12
Ethics committee reference number
IR.MAZUMS.REC.1397.241
Health conditions studied
1
Description of health condition studied
Radiation-induced acute proctitis in prostate cancer patients
ICD-10 code
K62.7
ICD-10 code description
Radiation proctitis
Primary outcomes
1
Description
Development of Proctitis
Timepoint
Before intervention, then every 2 weeks for eight weeks after intervention
Method of measurement
Based on clinical presentation
2
Description
Proctitis severity
Timepoint
Before intervention, then every 2weeks for eight weeks after intervention
Method of measurement
Based on Radiation therapy oncology group (RTOG) and CTCAE–v5-2017 criteria
Secondary outcomes
1
Description
Social-Psychological state
Timepoint
Before intervention, then every 2weeks for eight weeks after intervention
Method of measurement
Based on Hospital Anxiety-Deprresion (HAD) scale
2
Description
Quality of life
Timepoint
Before intervention, then every 2weeks for eight weeks after intervention
Method of measurement
Based on questionnaire defines the Quality of Life from 0 to 5.
Intervention groups
1
Description
Intervention group: Aloe Vera ointment 3% for the first day of radiotherapy every 12 hours, rectal use for 2 months
Category
Prevention
2
Description
Control group: Placebo of Aloe Vera ointment 3% for the first day of radiotherapy every 12 hours, rectal use for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Radiation Therapy Center in Babolsar
Full name of responsible person
Abed Besmel
Street address
Shahid Rajaee Radiotherapy center, Shilat Square, Shariati Ave
City
Babolsar
Province
Mazandaran
Postal code
4847193696
Phone
+98 11 3528 9259
Fax
+98 11 3528 9262
Email
rajaee@mubabol.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Vice chancellor for research of Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Province
Mazandaran
Postal code
4818893716
Phone
+98 11 3448 4854
Email
majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
4818893716
Phone
+98 11 3354 3082
Email
Esalehifar@Mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Faculty member, Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square
City
Sari
Province
Mazandaran
Postal code
4818893716
Phone
+98 11 3354 3082
Email
esalehifar@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Payambar Azam's Complex of Mazandaran University of Medical Sciences, kilometer 18 of Farah Abad Blvd, Khazar square
City
Sari
Province
Mazandaran
Postal code
4818893716
Phone
0098112261700
Fax
+98 11 3354 3084
Email
esalehifar@mazums.ac.ir
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