Study of the Effectiveness of Henna Topical Formulation for the Prevention and Control of Hand-Foot Syndrome Complicated by Capsitibine in Patients with Different Malignancies
To evaluate the efficacy of topical henna formulation in preventing and controlling of local Hand-Foot Syndrome from Capecitabine in patients with cancer.
Design
randomized, superiority, parallel group, double blind, controlled trial with blinded participants and investigator.
Settings and conduct
Cancer patients more than 18 years old who had candidate for capsitibine therapy will enroll. The study will be conducted at department of oncology of the University Hospital Emam Reza, and department of oncology of the University Hospital Omid Mashhad. randomization will be performed after informed consent was obtained. The randomization schedule will be generated by computer. Allocations will be sealed in opaque, numbered envelopes that will be opened after collection of the baseline data. The randomization data will not be available to the investigators. In intervention group Patients receive topical henna formulation twice daily . In placebo group, placebo made by the faculty of pharmacy will be used twice a day by the patient. patients underwent the same evaluations at 1 and 2 months after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Cancer Patients candidate for capsitibine Therapy. Exclusion criteria: Patients that Increased liver enzymes; increased blood creatinine; have fever or severe neutropenia; have Diabetes; autoimmune diseases; taking immunosuppressants and anti-inflammatory drugs excluded
Intervention groups
Intervention group; Patients receive topical alpha ointment twice daily.
Placebo group; College-made placebo will be used twice daily by the patient.
Main outcome variables
Evaluation of the side effects and symptomatic improvement after treatment, as measured by the NCI criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181230042179N1
Registration date:2019-11-30, 1398/09/09
Registration timing:registered_while_recruiting
Last update:2019-11-30, 1398/09/09
Update count:0
Registration date
2019-11-30, 1398/09/09
Registrant information
Name
Sara Rasta
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 6082
Email address
rastas951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effectiveness of Henna Topical Formulation for the Prevention and Control of Hand-Foot Syndrome Complicated by Capsitibine in Patients with Different Malignancies
Public title
The Effectiveness of Henna Topical Formulation for the Prevention and Control of Hand-Foot Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cancer Patients Candidate for Capsitibine Therapy
Exclusion criteria:
Increased liver enzymes
increased blood creatinine
fever, and severe neutropenia that need to be stopped
Having Diabetes
Use of immunosuppressant and anti-inflammatory drugs
Having autoimmune diseases
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, randomly allocate a participant to a treatment group. Prepared a list of all permutations for the sample size, selected one of them and based on arrangement allocated participants to a treatment and control groups with sealed envelope. Participants will be unaware of the type of intervention. Investigator will be unaware of the type of intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining informed consent, participants were classified into intervention groups and were not aware of the type of intervention. Researcher and Care provider unaware of the type of intervention when investigate complications and treatment .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Building Ghoreshi, Central Organization of Mashhad University of Medical Sciences, Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.624
Health conditions studied
1
Description of health condition studied
Malignant neoplasm Cancer
ICD-10 code
C00
ICD-10 code description
Malignant neoplasm of lip
2
Description of health condition studied
Malignant neoplasm Cancer
ICD-10 code
C96
ICD-10 code description
Other and unspecified malignant neoplasms of lymphoid, hematopoietic and related tissue
Primary outcomes
1
Description
side effects
Timepoint
Once a week for up to two months after intervention
Method of measurement
NCI Criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: topical henna formulation
Category
Treatment - Drugs
2
Description
Control group: placebo ointment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Sareh Hosseini
Street address
Emam Reza Hospital, Emam Reza square, Ibn Sina Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 2031
Email
HOSSEINIS@MUMS.AC.IR
2
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Sareh Hosseini
Street address
Omid Hospital, Kohsangi Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Email
HOSSEINIS@MUMS.AC.IR
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Building Ghoreshi, Central Organization of Mashhad University of Medical Sciences, Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sareh Hosseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Radiotherapy
Street address
mashhad univesity of medical science, Azadi Square, Vakil Abad Avenue, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
HOSSEINIS@MUMS.AC.IR
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sareh Hosseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Radiotherapy
Street address
mashhad univesity of medical science, Azadi Square, Vakil Abad Avenue, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
HOSSEINIS@MUMS.AC.IR
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sareh Hosseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Radiotherapy
Street address
mashhad univesity of medical science, Azadi Square, Vakil Abad Avenue, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
Hosseinis@mums.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