Comparison of the effectiveness of discolored Henna cream with placebo in the treatment of cutaneous problems induced by chemotherapy and radiotherapy in cancer patients
The assessment of efficacy of discolored Henna cream in the improvement of skin reactions induced by treatment of cancer
Design
This study was designed as a double-blind, placebo-controlled, parallel and randomized phase 3 clinical trial. 44 patients entered to two groups A or B based on simple randomization method.
Settings and conduct
written informed consent was achieved from involved patients in the Shohadaye Haftetir hospital. It has recommended to all patients in two groups that two times a day wash the skin reaction involved area with mild soap and then use the topical cream as enough. Skin reaction grade were determined by Common Terminology Criteria for Adverse Events (CTCAE). Duration of treatment was two weeks to one month according to skin reaction severity. At the first and end of the study, skin reaction severity was assessed by photo and questionnaire was completed.
Participants/Inclusion and exclusion criteria
Cancer patients from both sex, having cutaneous problems induced by chemotherapy or radiotherapy are involeved in this study. Skin cancer and skin infections and sensitivity to herbal products including Henna are exclusion criterias.
Intervention groups
Group A will receive discolored Henna cream on the skin reaction involved area two times a day for two weeks to one month. Group B will receive topical placebo with the same protocol as group A.
Main outcome variables
Severity of skin reaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160813029327N7
Registration date:2018-02-24, 1396/12/05
Registration timing:retrospective
Last update:2018-02-24, 1396/12/05
Update count:0
Registration date
2018-02-24, 1396/12/05
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-11-16, 1396/08/25
Trial completion date
empty
Scientific title
Comparison of the effectiveness of discolored Henna cream with placebo in the treatment of cutaneous problems induced by chemotherapy and radiotherapy in cancer patients
Public title
Efficacy of Henna cream in cutaneous problems induced by cancer therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patiens having cancer
Patients having cutaneous problems induced by chemotherapy or radiotherapy
Exclusion criteria:
Patients having skin cancer
Patients having skin infections
Patients having allergy to herbal products including Henna
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In this investigation, simple randomization method based on random numbers table was used.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this investigation participants, investigator, care providers and outcome assessors were blinded that wich patient will receive Henna or placebo topical cream.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Pharmaceutical Sciences
Street address
#99, Yakhchal Ave., Shariati st.
City
Tehran
Province
Tehran
Postal code
19395_6466
Approval date
2016-10-24, 1395/08/03
Ethics committee reference number
IR.IAU.PS.REC.1395.22
Health conditions studied
1
Description of health condition studied
Skin reaction induced by radiotherapy, Hand and foot syndrom induced by chemotherapy
ICD-10 code
L58.0, L27
ICD-10 code description
Acute radiodermatitis, Localized skin eruption due to drugs and medicaments
Primary outcomes
1
Description
Skin reaction severity induced by radiotherapy
Timepoint
Befor intervention and at the end of the intervention
Method of measurement
Based on Common Terminology Criteria for Adverse Events and Skindex-16 questionnaire
2
Description
Hand and foot syndrom severity
Timepoint
Befor intervention and at the end of the intervention
Method of measurement
Based on Common Terminology Criteria for Adverse Events and Skindex-16 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients use the discolored Henna cream on the skin reaction involved erea two times a day for two weeks to one month according to skin reaction severity
Category
Treatment - Drugs
2
Description
Control group: Patients use the topical placebo on the skin reaction involved erea two times a day for two weeks to one month according to skin reaction severity
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Hafte Tir hospital
Full name of responsible person
Atefeh Khodabakhshi
Street address
Shahid Rajaei St., Rey City
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 5522 8580
Email
Atefe.c72@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Doctor Seyed Jalalodin Hoseini Ghonche
Street address
Yakhchal St., Shariati st.
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 2264 0051
Email
mehdirj@aol.co.uk
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
Private
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
Atefeh Khodabakhshi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Medical Pharmacy
Street address
#99, Yakhchal Ave, Shariati st.
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0051
Email
Atefe.c72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr mehdi rajabi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
#99, Yakhchal Ave, Shariati st.
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0051
Email
Mehdirj@aol.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Atefeh Khodabakhshi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Pharmacy
Street address
#99, Yakhchal Ave, Shariati st.
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0051
Email
Atefe.c72@gmail.com
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