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Comparison of the therapeutic efficacy of pregabalin and duloxetine in peripheral neuropathy induced by taxanes containing chemotherapy regimens in women with breast cancer, a randomized clinical trial.

Protocol summary

Summary
This study is a randomized, double-blind, single-center, phase II clinical trial in Tuba Clinic of Sari. 82 eligible patients were 18 years or older, had at least grade 1 sensory pain based on the NCI Common Terminology Criteria for Adverse Events grading scale and reported 4 on a 10-point scale, average neuropathic pain. Participants with other clinical conditions that cause neuropathies, such as diabetes or trauma, alcohol abuse, central nervous system diseases, heart, hepatic and renal failure, glaucoma, depression, anxiety, bipolar, psychotic disorders, suicidal ideation, receiving other neurotoxic chemotherapy drugs, having concomitant use of MAOI, BZD, gabapentin and females during pregnancy or lactation were ineligible. This study will be blinded for patients and researchers. Patients in duloxetine group, will received 30 mg/day orally for the first week and 30 mg BD for the next for 6 weeks. Patients in pregabalin group, will received 75 mg/day orally for the first week and 75 mg BD (max: 75 mg TDS) for the next for 6 weeks. Sensory neuropathy , severity of pain and quality of life at base line and 3,6 weeks after intervention, will be assessed according to the NCI-CTCAE, VAS and EORTC QLQ-C30 (version 3) respectively.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201602112027N5
Registration date: 2016-07-13, 1395/04/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-13, 1395/04/23
Registrant information
Name
Ebrahim Salehifar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1311 6546
Email address
esalehifar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
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
Comparison of the therapeutic efficacy of pregabalin and duloxetine in peripheral neuropathy induced by taxanes containing chemotherapy regimens in women with breast cancer, a randomized clinical trial.
Public title
The therapeutic effects of pregabalin and duloxetine in the treatment of nerve pain caused by certain chemotherapy drugs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of more than 18 y; NCI Common Terminology Criteria for Adverse Events scale (NCI grade> 1); Minimum rating of NRS scale: 4 (0-10) Exclusion criteria: Having other clinical conditions that cause neuropathies, such as diabetes or trauma; Alcohol abuse; History of central nervous system diseases; History of heart, hepatic and renal failure (creatinine clearance below 60ml/min); History of glaucoma; History of depression, anxiety, bipolar, psychotic disorders and suicidal ideation; Receiving other neurotoxic chemotherapy drugs; Having concomitant use of MAOI, BZD and gabapentin; Females during pregnancy or lactation; Patients who have received pregabalin or duloxetine in recent 15 days; Having concomitant use of analgesics or effective on nerve activity drugs such as vitamin B12, lamotrigine, valproate and TCA (except pregabalin or duloxetine) will be excluded if they spent a total of 7 days washout, the patients also can be studied; Concomitant use of selected analgesics was allowed (eg, nonsteroidal anti-inflammatory drugs , acetaminophen, aspirin,..) but only patients receiving stable doses in the 2 weeks before randomization could participate: (1) no new analgesics were added, (2) no analgesics were discontinued and (3) the weekly 24-hour total analgesic dose did not fluctuate up or down by more than 10% in the 2weeks before study registration
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 82
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences, Faculty of Pharmacy
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
City
Sari
Postal code
861-48175
Approval date
2016-01-26, 1394/11/06
Ethics committee reference number
IR.MAZUMS.REC.94-1897

Health conditions studied

1

Description of health condition studied
Chemotherapy induced peripheral neuropathy
ICD-10 code
62.2
ICD-10 code description
Polyneuropathy due to other toxic agents

Primary outcomes

1

Description
Sensory neuropathy
Timepoint
Before intervention, three weeks after intervention and six weeks after intervention
Method of measurement
According to the NCI Common Terminology Criteria for Adverse Events grading scale

2

Description
Neuropathic pain
Timepoint
Before intervention, three weeks after intervention and six weeks after intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Quality of life
Timepoint
Before intervention, three weeks after intervention and six weeks after intervention
Method of measurement
EORTC QLQ-C30 (Version 3) questionnaire

2

Description
Side effects
Timepoint
Three weeks after intervention and six weeks after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group 1: Pregabalin 75 mg/day orally for the first week and 75 mg BD (max: 75 mg TDS) for the next for 6 weeks
Category
Treatment - Drugs

2

Description
Intervention group 2: Duloxetine 30 mg/day orally for the first week and 30 mg BD for the next for 6 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tuba Clinic of Mazandaran University of Medical Sciences
Full name of responsible person
Avan Razieh
Street address
Tuba Clinic of Mazandaran University of Medical Sciences, Khazar Blvd, Sari, Mazandaran Province
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Enayati Ahmad ali
Street address
Vice chancellor for research, Moalem square, Sari
City
Sari
Grant name
Grant code / Reference number
30303
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences, Faculty of Pharmacy
Full name of responsible person
Salehifar Ebrahim
Position
Board Certified Clinical Pharmacist, Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
Esalehifar@Mazums.ac.ir; Salehifare@yahoo.com; esalehifar52@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences, Faculty of Pharmacy
Full name of responsible person
Salehifar Ebrahim
Position
Board Certified Clinical Pharmacist
Other areas of specialty/work
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
Esalehifar@Mazums.ac.ir; Salehifare@yahoo.com; esalehifar52@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences, Faculty of Pharmacy
Full name of responsible person
Salehifar Ebrahim
Position
Board Certified Clinical Pharmacist, Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
Esalehifar@Mazums.ac.ir; Salehifare@yahoo.com; esalehifar52@gmail.com
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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