Evaluation of topical Costus sp. preparation efficacy in treatment of taxane induced peripheral neuropathy in cancer patients : a pilot study and a randomised controlled trial
Evaluation effects of topical Costus sp. preparation on taxane induced peripheral neuropathy in cancer patients
Design
Two arm parallel group randomized clinical trial, Double-blinded
Settings and conduct
50 cancer patients 18 to 80-year-old who have taxane induced peripheral neuropathy, that are undergoing chemotherapy or at least two months after chemotherapy will enter the study,
if a neurologist discovers that their neuropathy is due to chemotherapy with taxanes. Regardless of the number of chemotherapy courses, based on entry criteria, they will be entered in the study. Patients will be divided into two groups by simple random method. Group (A) will receive drug (Costus sp ointment), Group (B) will receive placebo (placebo ointment).
Participants/Inclusion and exclusion criteria
Entry requirements:
Cancer patients
Patients undergoing chemotherapy or complete chemotherapy in the last two months
Patients with complained of neuropathy whose neuropathy is due to chemotherapy with taxane drugs
Having symptoms of peripheral neuropathy in all four organs
Having at least B grade based on the PNQ questionnaire
Having at least 18 years and maximum 80 years
Conditions of failure to enter:
Diabetes
Renal failure
Brain metastasis
Having carpal tunnel syndrome
Intervention groups
There are two intervention groups in this study, one group gets a topical Costus sp. ointment, and the other group receives the placebo ointment
Main outcome variables
Chemotherapy Induced Peripheral Neuropathy score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131218015860N5
Registration date:2019-03-10, 1397/12/19
Registration timing:retrospective
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
Ghazaleh Heydarirad
Name of organization / entity
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Behe
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 6027
Email address
dr.ghazalrad@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
2020-02-19, 1398/11/30
Scientific title
Evaluation of topical Costus sp. preparation efficacy in treatment of taxane induced peripheral neuropathy in cancer patients : a pilot study and a randomised controlled trial
Public title
Evaluation of topical Costus sp. preparation efficacy in treatment of neuropathy in cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cancer
Patients undergoing chemotherapy or Complete chemotherapy in the last two months
Patients with complained of neuropathy whose neuropathy is due to chemotherapy with taxane drugs
Having symptoms of peripheral neuropathy in all four organs
Having at least B grade based on the PNQ questionnaire
Having at least 18 years and maximum 80 years
simple randomization: The numbers from 1 to 50 is written on 50 papers and placed inside a bag. Each time a patient enters the study according to entry criteria, a paper is removed from the bag and the number that is wirtten on the paper will be the number of intervention medication (which can be a Costus sp ointment or placebo).
Blinding (investigator's opinion)
Double blinded
Blinding description
Costus sp and placebo was coded, patient and researcher were blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Research of Shahid Beheshti University of Medical sciences
Street address
Shahid Beheshti University of Medical sciences, Daneshju Blv.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2018-01-07, 1396/10/17
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.842
Health conditions studied
1
Description of health condition studied
Neoplastic (malignant) related neuropathy
ICD-10 code
G62.0
ICD-10 code description
Drug-induced polyneuropathy
Primary outcomes
1
Description
Severity of neuropathy based on patient's statements
Timepoint
14, 21 and 28 days after interference
Method of measurement
Neuropathy Severity Scale questionnaire
Secondary outcomes
1
Description
Score of "The Cancer Neuropathy Scale"
Timepoint
The weeks of 0 and 4 after treatment
Method of measurement
The Cancer neuropathy Scale questionnaire
Intervention groups
1
Description
Intervention group: cancer patients with taxane induced peripheral neuropathy, receiving ointment of Coctus sp, 1 mg three times daily for four weeks
Category
Treatment - Drugs
2
Description
Control group: cancer patients with taxane induced peripheral neuropathy, receiving ointment of placebo, 1 mg three times daily for four weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Dr. Ghazaleh Heydarirad
Street address
Imam Hossein hospital - Madani st - Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 2338
Fax
Email
info.rhmc@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Somayeh Esmaeili
Street address
Shams Alley, Vali-e-Asr Street, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
sesmaeili@sbmu.ac.ir
Grant name
Research Assistant of Shahid Beheshti University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ghazaleh Heydarirad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shams Alley, Vali-e-Asr Street, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
ghazalrad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ghazaleh Heydarirad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shams Alley, Vali-e-Asr Street, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
ghazalrad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ghazaleh Heydarirad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
ghazalrad@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the result of the clinical trial
When the data will become available and for how long
6 month later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After publication of the extracted article of the clinical trial
From where data/document is obtainable
Sending Email to the researchers
What processes are involved for a request to access data/document