Protocol summary

Summary
The aim of this study was to evaluate the protective effect of curcumin using different quality of life indicators and blood parameters affecting liver and kidney damage induced by anticancer drugs in chemotherapy. The aim of this study is to investigate the incidence of all cancer patients from May 1395 to December 1395 were treated and their disease has been in medical records and have been in operation for 10 days since their last surgery and are able to move or perform their normal activities. Also, all patients who were unavailable due to the lack of referral to their information center were excluded, and those who did not wish to cooperate during the course of the study to answer the questionnaire questions and conduct blood tests were excluded.  The study population was divided into 80 cancer patients treated with chemotherapy drugs that were divided into two groups of controls treated with curcumin. And then subjected to treatment with a dose of 600 mg curcumin for 9 weeks and 12 hours.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201708021165N23
Registration date: 2017-10-27, 1396/08/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-27, 1396/08/05
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baghiyyatollah University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The protective effect of curcumin on the side effects of anticancer drugs in chemotherapy
Public title
The protective effect of curcumin on the side effects of anticancer drugs in chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Cancer patients treated between May 2016 and December 2016; Ten days after the last surgery; able to move or perform their normal activities;  Exclusion criteria: Failure to return to the center during the course of treatment; Failure to cooperate in blood tests; Patient's death.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baqiyatallah Medical Sciences University
Street address
Mulla sadra Street in Tehran.
City
tehran
Postal code
Approval date
2017-04-03, 1396/01/14
Ethics committee reference number
ir.tums.ikhc.rec.13963.2008

Health conditions studied

1

Description of health condition studied
Cancer patients treated with chemotherapy
ICD-10 code
Z09.2
ICD-10 code description
Follow-up examination after chemotherapy for other conditions

Primary outcomes

1

Description
liver damage
Timepoint
Baseline, three months after the start of the intervention
Method of measurement
Questionnaire

2

Description
renal damage
Timepoint
Baseline, three months after the start of the intervention
Method of measurement
Questionnaire

3

Description
Changes in blood enzymes
Timepoint
Baseline, three months after the start of the intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Reduce the quality of life
Timepoint
Baseline, three months after the start of the intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Patients of the treatment group will receive Curcumin capsule (600 mg) every 12 hours for 9 weeks.
Category
Treatment - Drugs

2

Description
Patients in the control group will receive placebo every 12 hours, for 9 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Baghiyyatollah University of Medical Sciences
Full name of responsible person
Yunes Panahi
Street address
Baghiyyatollah University of Medical Sciences
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baghiyyatollah University of Medical Sciences
Full name of responsible person
Dr. Seyyed Hassan Saadat
Street address
tehran
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baghiyyatollah 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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr.YunesPanahi
Position
Pharmacy dr
Other areas of specialty/work
Street address
Mollasadr Avn
City
Tehran
Postal code
1435916471
Phone
+98 21 8248 2503
Fax
Email
Yunespanahi@bmsu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr.YunesPanahi
Position
Dr.pharmacy
Other areas of specialty/work
Street address
Mollasadra avn
City
Tehran
Postal code
1435916471
Phone
+98 21 8248 2503
Fax
Email
Yunespanahi@bmsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hossein Amirfakhrian
Position
Master of Radioparmacy
Other areas of specialty/work
Street address
Farahabad avn
City
Sari
Postal code
Phone
+98 11 3337 5710
Fax
Email
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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