Comparison of the therapeutic effects of oral duloxetine alone and with combination gel on reduction of symptoms of chemotherapy-induced peripheral neuropathy
The aim of this study is to compare the therapeutic effects of oral duloxetine alone and with a combination gel (containing baclofen, amitriptyline, and ketamine) to reduce Chemotherapy-induced peripheral neuropathy symptoms.
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
The present study will be done on 90 patients referring to Shahrekord Ayatollah Kashani hospital under treatment with neurotoxic chemotherapy drugs, who developed peripheral neuropathy symptoms.They were selected by convenience sampling.
Participants/Inclusion and exclusion criteria
Inclusion criteria were being patients under treatment with neurotoxic chemotherapy drugs, Which have symptoms of peripheral neuropathy and have normal blood calcium and magnesium levels; Patients with diabetes or other causes of peripheral neuropathy also patients with History of severe hypersensitivity to duloxetine will not enrolled in the study.
Intervention groups
Patients will divide into three groups of 30 each. Group A will receive oral duloxetine 30 mg once daily along with topical placebo gel 1.3 g twice a day. Group B will receive oral duloxetine 30 mg once daily along with topical combination gel (10 mg of baclofen, 40 mg of amitriptyline, and 20 mg of ketamine) twice daily. 1.3 g. The placebo gel contained a gel base without pharmaceutical compounds. The combination gel will be applied to areas of pain, numbness, or paresthesia and will not be applied to more than 4 areas in each turn of application. Group C will receive a placebo gel twice a day 1.3 g (one table spoon). Before and 4 weeks after intervention, all patients will be examined by a questionnaire, for 20 symptoms of peripheral neuropathy which was derived from the the international instrument QLQ-CIPN20,
Main outcome variables
Changes in the symptoms of neuropathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110514006480N16
Registration date:2018-08-01, 1397/05/10
Registration timing:registered_while_recruiting
Last update:2018-08-01, 1397/05/10
Update count:0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2018-11-01, 1397/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effects of oral duloxetine alone and with combination gel on reduction of symptoms of chemotherapy-induced peripheral neuropathy
Public title
Effects of oral duloxetine on reduction of symptoms of peripheral neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under treatment with neurotoxic chemotherapy drugs, Which have symptoms of peripheral neuropathy
Normal blood calcium and magnesium levels
Exclusion criteria:
Having diabetes and other causes of peripheral neuropathy
History of severe hypersensitivity to duloxetine
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into three groups by simple random sampling and Using three categories of cards that listed on them the letters A, B and C.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study considering the use of similar drug forms in all three groups participants, researcher, as well as the assessor, are not aware of the type of drug used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Deputy of Research and Technology, Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2017-02-01, 1395/11/13
Ethics committee reference number
IR.SKUMS.REC.1395.290
Health conditions studied
1
Description of health condition studied
Chemotherapy-induced peripheral neuropathy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean scores of peripheral neuropathy symptoms in LQ-CIPN20 questionnaire
Timepoint
Before the intervention, 4 week after treatment with duloxetine
Method of measurement
LQ-CIPN20 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients will receive oral duloxetine 30 mg once daily (in the morning) along with topical placebo gel 1.3 g twice (morning and night) a day
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients will receive oral duloxetine 30 mg once daily (morning) along with topical combination gel (10 mg of baclofen, 40 mg of amitriptyline, and 20 mg of ketamine) twice daily (morning and night) 1.3 g.
Category
Treatment - Drugs
3
Description
Control group: Patients will receive placebo gel twice a day (morning and night) 1.3 g.