Chemotherapy induced neuropathy is a dose limiting and disturbing side effect of taxane which impacts the quality of life in cancer survivors.
Purpose of this sudy is to to assess the efficacy of concurrent gabapentin with paclitaxel based chemotherapy in preventing chemotherapy induced neuropathy in breast cancer patients
This randomized controlled double-blinded clinical trial wiil be done in 2010-2011 in Cancer institute, Tehran, Iran. Forty women aged 18-65 with pathologically confirmed non-metastatic breast cancer after completion of four cycles of doxorubicin and cyclophosphamide will be enrolled. The subjects randomized into two groups of paclitaxel chemotherapy with gabapentin 300mg/three times a day oral or placebo for two weeks started at day 1 of each cycle. Nerve conduction studies would be done before the first and 6 weeks after the last cycle of paclitaxel. Between the cycles the patients would be visited and questioned of the symptoms of neuropathy graded based on CTCAE4. Two groups will be compared based on the relative frequency of neuropathy and NCV studies.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021132494N1
Registration date:2017-04-30, 1396/02/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-30, 1396/02/10
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
Bakhtar Bioshimi Company
Expected recruitment start date
2010-07-31, 1389/05/09
Expected recruitment end date
2011-07-31, 1390/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Gabapentin for the Prevention of Paclitaxel Induced Peripheral Neuropathy
Public title
Prevention of Chemotherapy Induced Neuropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Women who have pathologically confirmed non metatstatic breast cancer; aged 18-65; candidate for receiving 4 course of paclitaxel ; good performance status (based on Karnofsky Score)
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 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
93-02-30-25786
Health conditions studied
1
Description of health condition studied
chemotherapy induced neuropathy
ICD-10 code
y43.3
ICD-10 code description
Other antineoplastic drugs
Primary outcomes
1
Description
taxane induced neuropathy
Timepoint
befor and after each chemotherapy session
Method of measurement
taking history and physical exam
Secondary outcomes
1
Description
objective neuropathy
Timepoint
befor begining chemotherapy session and 6 week after last chemotherapy session
Method of measurement
nerve conducting study
Intervention groups
1
Description
in intervention group Gabapentin is prescribed 300mg orally for the first day, 300mg every 12 hour for the second day and 300mg every 8 hour for the third to fourteenth day of each chemotherapy cycle.
Category
Treatment - Drugs
2
Description
in control group placebo is prescribed orally one capsule for the first day, one capsule every 12 hour for the second day, one capsule every 8 hour for the third to fourteens day of 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., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bakhtar Bioshimi Company
Full name of responsible person
Reza Malekzadeh
Street address
Kermanshah Industrial Town, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bakhtar Bioshimi Company
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
Radiation Oncology Research Center, Cancer Institute , Imam Khomeini Hospital Complex
Full name of responsible person
Nima Mousavi Darzikolaee
Position
Resident of Radiation Oncology
Other areas of specialty/work
Street address
Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
1419733141
Phone
+98 21 6694 8679
Fax
Email
mousavi-n@razi.tums.ac.ir
Web page address
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
Resident of Radiation Onclology
Other areas of specialty/work
Street address
Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
1419733141
Phone
+98 21 6694 8679
Fax
+98 21 6658 1633
Email
mousavi-n@razi.tums.ac.ir
Web page address
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
Resident of Radiation Oncology
Other areas of specialty/work
Street address
Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
1419733141
Phone
+98 21 6694 8679
Fax
+98 21 6658 1633
Email
mousavi-n@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)