determining the preventive effect of corcomin on chemotherapy induced hepatotoxicity in patient with cancer
Design
double blinded randomized control clinical trial with parallel group design of 120 patients.we used random allocation software for randomization.
Settings and conduct
the study will be performed in Milad Hospital of Isfahan on cancer patients receiving taxanes, by dividing the subjects into control group and intervention, by randomization and researcher blinding methods.
Participants/Inclusion and exclusion criteria
including criteria
1-age between 30 and 60
2-definite diagnosis of cancer with chemotherapy indication
3-chemotherapy with paclitaxel and docetaxel
excluding criteria
1- taking Heparin,aspirin, clopidogrel, dipiridamol, warfarin, ticlopidine
2- pregnancy and lactation
3- past history of liver disease
4- peptic ulcer
5-gastrointestinal bleeding
Intervention groups
This study is a double-blind randomized controlled clinical trial of parallel groups to evaluate the prophylactic effect of Curcumin on cancer-induced hepatotoxicity. In this study, 60 cancer patients treated with DOCATAXLE or PICATAXLE diet met the inclusion criteria. They are randomly divided into 4 groups of control and treatment with 30 patients in each group. The treatment group receives one 450 mg Curcumin tablet per day, while the control group receives one tablet per day. Placebo receives. In both groups, at intervals before the intervention, 3 and 6 weeks after the intervention, ALT, AST, BILIRUBIN, ALP tests are performed by a laboratory that does not know the groups. Hepatotoxicity is determined by increasing each of these enzymes from the normal range. , Will be registered.
Main outcome variables
liver enzyme
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190918044815N1
Registration date:2020-09-21, 1399/06/31
Registration timing:retrospective
Last update:2020-09-21, 1399/06/31
Update count:0
Registration date
2020-09-21, 1399/06/31
Registrant information
Name
Danial Abasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 8246
Email address
sohrab137347@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
2020-02-20, 1398/12/01
Actual recruitment end date
2020-07-22, 1399/05/01
Trial completion date
2020-07-22, 1399/05/01
Scientific title
Evaluation of curcumin effect on prevention of hepatotoxicity induced by chemotherapeutic drugs in patients under outpatient canecr treatment
Public title
Evaluation of curcumin effect on prevention of hepatotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30 to 60 years
Definitive diagnosis of cancer that chemotherapyeutic treatment is indicated .
Treated with a regimen containing paclitaxel and docetaxel
Ability to take oral medication
Exclusion criteria:
Gastrointestinal bleeding
pregnancy and Breastfeeding
using heparin, aspirin, Clopidogrel, dipiridamol ,warfarin and ticlopidine
Past medical history of hepatic disease
Past medical history of peptic ulcer
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization was performed using random allocation software. The randomization method was of permutation block type with blocks of volume 4. For each person who entered the study, a code was obtained from the software and it was determined which group it belongs to (intervention or control).
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blinded study.in this study patients,outcome evaluator and statistical analyzer are blind.each patient is belong to group A or B and only the researcher knows which group is intervention group and which is control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of medical sciences
Street address
Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-02-14, 1398/11/25
Ethics committee reference number
IR.MUI.MED.REC.1398.579
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
C50.1
ICD-10 code description
Malignant neoplasm of central portion of breast
Primary outcomes
1
Description
Aspartate Aminotransferase
Timepoint
before intervention and 3 and 6 weeks after intervention
Method of measurement
laboratory
2
Description
alanine transaminase
Timepoint
before intervention and 3 and 6 weeks after intervention
Method of measurement
laboratory
3
Description
Alkaline phosphatase
Timepoint
before intervention and 3 and 6 weeks after intervention
Method of measurement
laboratory
4
Description
bilirubin
Timepoint
before intervention and 3 and 6 weeks after intervention
Method of measurement
laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At first, 30 people were randomly selected from permutation block and received a 450 mg curcumin tablet daily and at intervals before the intervention, 3 and 6 weeks after the intervention, ALT, AST, BILIRUBIN, ALP tests by A laboratory that does not know the groups will be checked and the hepatotoxicity determined by the increase of each of these enzymes from the normal range will be recorded.
Category
Treatment - Drugs
2
Description
Control group: First, 30 people are randomly selected from the permutation block type and receive one placebo pill daily. At intervals before the intervention, 3 and 6 weeks after the intervention, ALT, AST, BILIRUBIN, ALP tests are checked by a laboratory that does not know the groups, and the hepatotoxicity is determined by increasing each of these enzymes from the normal range. Will be registered.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad hospital
Full name of responsible person
Dr Ali Hajigholami
Street address
Hezajarib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3258 5625
Email
sohrab137347@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoyjavanmard
Street address
Isfahan university of medical sciences,Hezarjarib Ave, Daeshgah Blvd
City
Isfahan
Province
Isfehan
Postal code
81346-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Hajgholami
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Isfahan university of medical sciences,Hezarjarib Ave, Daneshgah Blvd
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 2225 5658
Email
sohrab137347@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Hajigholami
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Isfahan university of medical sciences,Hezarjarib Ave, Daneshgah Blvd,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3225 2589
Email
sohrab137347@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
ali hajigholami
Position
associated professore
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Isfahan university of medical sciences-Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 2226 5486
Email
sohrab137347@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