Determination of the efficacy of topical product Citrullus colocynthis fruit oil on the symptoms of peripheral neuropathy due to chemotherapy in cancer patients
Design
Two arm parallel group randomised clinical trial, doable blinded
Settings and conduct
Design of the study: Patients with cancer referring to Shahid Modarres Hospital of Tehran who have symptoms of chemotherapy-induced peripheral neuropathy.
In order to blind the investigator, medications are named as "A" for Citrullus colocynthis oil and B for placebo. The patient don't aware of the type of drug he/she is assigned to. In addition, the groups are entered into statistical analysis as "A" and "B".
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Patients with cancer who have symptoms of peripheral neuropathy 2.The time period between patient's visit for enrolling to the study and the last time receiving chemotherapy is maximum two months 3. A neurologist recognizes that patient's neuropathy is due to chemotherapy 4. Age between 18-80 years old
Exclusion criteria: . 1. Patients with diabetes mellitus 2. Patients with brain metastasis 3. Patients with carpal tunnel syndrome 4. Unwillingness to participate in the study 5. Emerging acute psychological symptoms such as depression (and taking medication) 6. Deficiency or high levels of vitamin B6 (according to the doctor's interview and examination) 7.Any positive history of allergic reaction or complications due to Citrullus colocynthis 8. Patients with serious illness
Intervention groups
Group A: Use of topical product of Citrullus colocynthis fruit oil twice daily in upper and lower extremities
Group B: Use of Placebo (fluid paraffin) twice daily in the upper and lower extremities
Main outcome variables
1. Chemotherapy Induced Peripheral Neuropathy score
2. Symptoms and concerns associated specifically with chemotherapy-induced neuropathy score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150825023753N5
Registration date:2018-02-16, 1396/11/27
Registration timing:registered_while_recruiting
Last update:2018-02-16, 1396/11/27
Update count:0
Registration date
2018-02-16, 1396/11/27
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-03-16, 1396/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of topical Citrullus colocynthis fruit oil efficacy in treatment of chemotherapy-induced peripheral neuropathy in cancer patients
Public title
Effect of Citrullus colocynthis on neurological symptoms caused by cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cancer who have symptoms of peripheral neuropathy
The duration between the patient's visit for enrolling to the study and the last time receiving chemotherapy is at most two month
A neurologist will recognize that their neuropathy is due to chemotherapy
Age between 18-80 years old
Exclusion criteria:
Patients with diabetes mellitus
Patients with brain metastasis
Patients with carpal tunnel syndrome
Unwilling to participate in the study
Creating acute psychological symptoms such as depression (such as taking medication)
Deficiency or high levels of vitamin B6 (according to your doctor's interview and examination)
Any positive history of allergic reaction or complications due to uising Citrullus colocynthis
Patients with serious illness
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation software Ink was used to create a randomization table
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the investigator, medications (extracts) were named A (Citrullus colocynthis oil) and B (Placebo). The patient was not aware of the type of drug he was assigned to. The groups were also coded A and B to the statistical analyzer.
Placebo
Used
Assignment
Parallel
Other design features
Patients who is known case of cancer and has neurological complications due to chemotherapy and is in the range of 18 to 80 years old and has all the conditions for entry into the study.
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
2017-10-22, 1396/07/30
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.448
Health conditions studied
1
Description of health condition studied
Chemotherapy-induced peripheral neuropathy
ICD-10 code
G62.0
ICD-10 code description
Drug-induced polyneuropathy
Primary outcomes
1
Description
Chemotherapy Induced Peripheral Neuropathy score
Timepoint
Before and after
Method of measurement
Using of Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT)
2
Description
Symptoms and concerns associated specifically with chemotherapy-induced neuropathy score
Timepoint
Before and after
Method of measurement
Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Topical use of Citrullus colocynthis fruit oil product, twice daily (morning and night), all four lower and upper extremities, from ankle to toe, and from wrist to fingertips, 1 cc for each limb group of patients for 1 month
Category
Treatment - Drugs
2
Description
Control group: Topical use of placebo (liquid paraffin) , twice daily (morning and night), all four lower and upper extremities, from ankle to toe, and from wrist to fingertips, 1 cc for each limb group of patients for 1 month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital, Tehran
Full name of responsible person
Dr. Nematollah Rostami
Street address
Shahid Modarres Hospital, Saadat Abad Ave
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2236 0635
Email
dnrostami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Nematollah Rostami
Street address
Shahid Modarres Hospital, Saadat Abad Ave,
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2236 0635
Fax
Email
dnrostami@gmail.com
Grant name
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 6027
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. Nematollah Rostami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Shahid Modarres Hospital, Saadat Abad Ave
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2236 0635
Email
dnrostami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
mmparvizi@gmail.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