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Evaluation of efficacy of topical formulation of silymarin in prevention and management of hand-foot syndrome induced by capecitabine in patients with gastrointestinal malignancies

Protocol summary

Summary
This study is a prospective, triple-blind, randomized clinical trial to compare the effects of topical silymarin1% with placebo in prevention of hand foot syndrome induced by capecitabine in patients with gastrointestinal cancers (esophagus, gastric, colorectal). In this study 40 patients with gastrointestinal tract cancer diagnosis referring to oncology ward of Imam Reza hospital, Mashhad, Iran who decided to be treated with chemotherapy regimen included capecitabine have been selected based on random number table to receive topical silymarin gel1% or placebo gel which produced by Goldaroo company. The placebo/silymarin formulations are defined as A or B by producer and the oncologist, pharmacy student and clinical pharmacist who analyzed the data are not aware of formulation type. They should use half knuckle of cream on the soles of the feet and a knuckle of cream on the palm of the hands twice a day. At the beginning of the study, we record patients’ characteristics like age, gender, weight, height, body surface area, past medical and drug history, type of chemotherapy regimen and its duration. In both groups, patients are followed regarding hand foot syndrome occurrence every three weeks for nine weeks based on WHO grading scale. The patients with grade 3 or 4 (based on WHO grading scale) of HFS who need to decrease the dosage of capecitabine will be excluded from this trial.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016110730621N1
Registration date: 2017-01-02, 1395/10/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-02, 1395/10/13
Registrant information
Name
Farzaneh Rezazadeh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 584 5302
Email address
rezazadehf901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-02-09, 1394/11/20
Expected recruitment end date
2016-12-10, 1395/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of topical formulation of silymarin in prevention and management of hand-foot syndrome induced by capecitabine in patients with gastrointestinal malignancies
Public title
evaluation of topical silymarin on dermal side effect induced by capecitabine in patients with gastrointestinal cancers
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: age between 18-70 years- gastrointestinal tract malignancies who treated with chemotherapy regimen included capecitabine exclusion criteria: hepatic failure (LFT >5times of upper limit normal, or >3time of upper limit normal and symptoms), renal failure (GFR<30), severe infection requiring antibiotic therapy, dissatisfaction of patient, history of allergy to silymarin, autoimmune disease history, diabetes mellitus, concomitant use of NSAIDs, corticosteroids, other immunosuppressive drugs
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Mashhad University of Medical Science
Street address
Ghoreishi building, daneshgah street
City
mashhad
Postal code
13944-91388
Approval date
2016-10-31, 1395/08/10
Ethics committee reference number
IR.MUMS.REC.1395.384

Health conditions studied

1

Description of health condition studied
Hand-foot syndrome
ICD-10 code
R21
ICD-10 code description
Rash and other nonspecific skin eruption

Primary outcomes

1

Description
hand-foot syndorme occurrence
Timepoint
at the begining of the study, at the end of third week after intervention, at the end of 6th week after intervention, and at the end of the 9th weekafter intervention
Method of measurement
grade of the WHO criteria for classification of hand-foot syndrome

Secondary outcomes

1

Description
hepatic transaminase level
Timepoint
At the beginning of the study, at the end of the third, 6th, and 9th weeks
Method of measurement
laboratory

2

Description
serum creatinine and BUN level
Timepoint
At the beginning of the study, at the end of the third, 6th, and 9th weeks
Method of measurement
laboratory

Intervention groups

1

Description
Silymarin topical gel 1% which produced by Goldaru Company, two times a day, one finger tip unit for soles of foots and half of a finger tip unit for soles of the hands for 9 weeks.
Category
Prevention

2

Description
placebo gel of silymarin which produced by Goldaru company, two times a day, one finger tip unit for soles of foots and half of a finger tip unit for soles of the hands for 9 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospita, Hematology and Oncology ward
Full name of responsible person
Dr Abolghasem Allahyari
Street address
Imam Reza Hospital- Imam Reza Squ.- Mashhad
City
Mashhad

2

Recruitment center
Name of recruitment center
Isar clinic
Full name of responsible person
Dr Abolghasem Allahyari
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi, Vice-chancellor of Research
Street address
E-Campus University of Mashhad-Iran Vakil Abad
City
Mashhad
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Science-Pharmacy faculty
Full name of responsible person
Dr Mohsen Tafaghodi
Position
Vice chancellor foe research, Mashhad University of Medical Science
Other areas of specialty/work
Street address
Vakil Abad- E-Campus University of Mashhad-Iran
City
Mashhad
Postal code
94159-45344
Phone
+98 915 584 5302
Fax
Email
tafaghodim@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Pharmacy, Ferdowsi University campus, Vakil Abad Blvd, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3882 3255
Fax
Email
elyasis@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Science-Pharmacy faculty
Full name of responsible person
Farzaneh Sadat Rezazadeh Shojaei
Position
Professional Doctorate of pharmacy student
Other areas of specialty/work
Street address
School of Pharmacy, Ferdowsi University campus, Vakil Abad Blvd, Mashhad
City
Mashhad
Postal code
Phone
00
Fax
Email
rezazadehf901@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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