The aim of this study was to evaluate the efficacy and safety of duloxetine for prevention of oxaliplatin induced peripheral neuropathy.
Design
Randomized double-blinded, Placebo-controlled phase 2 clinical trial. 23 patients should be enrolled in each group.
Settings and conduct
Radiation Oncology Research Center, Cancer Institute, Imam Khomeini Hospital Complex.
Participants/Inclusion and exclusion criteria
The eligible patients were aged 18-75 with good performance status (ECOG<2) who had pathologically confirmed cancer and were candidate for receiving oxaliplatin (XELOX or FOLFOX) in the course of their cytotoxic treatment.
Intervention groups
Duloxetine capsule was given 60 mg orally from the first day of chemotherapy to day 14 of each chemotherapy cycle. The first dose was given 1 hour before the first course of chemotherapy. The placebo group received placebo the same way as duloxetine group.
Main outcome variables
Oxaliplatin Induced Peripheral Neuropathy (OIPN)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170211032494N2
Registration date:2019-01-04, 1397/10/14
Registration timing:retrospective
Last update:2019-01-04, 1397/10/14
Update count:0
Registration date
2019-01-04, 1397/10/14
Registrant information
Name
Nima Mousavi Darzikolaee
Name of organization / entity
Radiation Oncology Research Center, Cancer Institute, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 0945
Email address
mousavi-n@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
2016-07-22, 1395/05/01
Actual recruitment end date
2018-02-19, 1396/11/30
Trial completion date
2018-02-19, 1396/11/30
Scientific title
Efficacy of Duloxetine for the prevention of Oxaliplatin Induced Peripheral Nephropathy (OIPN)- A double blinded placebo controlled phase 2 study
Public title
Prevention of Oxaliplatin Induced Peripheral Neuropathy (OIPN)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients have pathologically confirmed cancer; Aged 18-75; Candidate for receiving at least 4 courses of Oxaliplatin; Good performance status (based on ECOG)
Exclusion criteria:
History of diabetes mellitus; Previous neuropathy; Chronic renal or liver disease; Consumption of neurotoxic/neurotropic/neuroleptic drugs
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
46
Actual sample size reached:
39
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible patients were randomized into two groups using randomly assigned permuted blocks method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were known as group C or D. Neither staff responsible for gathering the data nor the patients were aware of the drug (placebo or Duloxetine) which was given to them by the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Radiation Oncology Research Center, Cancer Institute , Imam Khomeini Hospital Complex
Street address
Imam Khomeini Hospital Complex, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2016-04-26, 1395/02/07
Ethics committee reference number
IR.TUMS.REC.1395.2474
Health conditions studied
1
Description of health condition studied
Oxaliplatin Induced Peripheral Neuropathy (OIPN)
ICD-10 code
Y43.3
ICD-10 code description
Other anti neoplastic drugs
Primary outcomes
1
Description
Oxaliplatin Induced Peripheral Neuropathy (OIPN)
Timepoint
Before, During and after each chemotherapy cycle, 6 weeks after last chemotherapy cycle.
Method of measurement
Subjective evaluation by Common Terminology Criteria for Adverse Effect, Objective assessment by Nerve Conducting Study.
Secondary outcomes
1
Description
Safety profile of Duloxetine
Timepoint
Before, During and after each chemotherapy cycle, 6 weeks after last chemotherapy cycle.
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Duloxetine capsule (Duloxicap produced by Tadbir Kala-e Jam pharmaceutical company) was given 60 mg once a day orally from the first day to the day 14 of each cycle (7 days rest in 3 week courses). Patients were given at least 4 cycle of Oxaliplatin containing chemotherapy. The first capsule was given 1 hour before the chemotherapy administration.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule with the same appearance as Duloxetine capsule (produced by Tadbir Kala-e Jam pharmaceutical company) was given once a day orally from the first day to day 14 of each cycle (with 7 days rest in 3 week courses). The first capsule was given 1 hour before the chemotherapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiation Oncology Research Center, Cancer Institute, Imam Khomeini Hospital Complex
Full name of responsible person
Nima Mousavi Darzikolaee
Street address
Imam Khomeini Hospital Complex, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6694 8679
Fax
+98 21 6658 1633
Email
mousavi.nima@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeeian
Street address
Ghods avenue, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8163 3698
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
1
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Radiation Oncology Research Center, Cancer Institute , Imam Khomeini Hospital Complex
Full name of responsible person
Nima Nousavi Darzikolaee
Position
Radiation Oncologist
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Imam Khomeini Hospital Complex, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6694 8679
Fax
+98 21 6658 1633
Email
mousavi.nima@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Radiation Oncology Research Center, Cancer Institute , Imam Khomeini Hospital Complex
Full name of responsible person
Nima Nousavi Darzikolaee
Position
Radiation Oncologist
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Imam Khomeini Hospital Complex, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6694 8679
Fax
+98 21 6658 1633
Email
mousavi.nima@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Radiation Oncology Research Center, Cancer Institute , Imam Khomeini Hospital Complex
Full name of responsible person
Nima Mousavi Darzikolaee
Position
Radiation Oncologist
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Imam Khomeini Hospital Complex, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6694 8679
Fax
+98 21 6658 1633
Email
mousavi.nima@yahoo.com
Web page address
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
No - There is not 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