Determining and comparing the effect of Livergol on reducing peripheral neuropathies induced by cisplatin in patients undergoing chemotherapy
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 3 on 60 patients
Settings and conduct
In this randomized double-blind clinical trial study, 60 cancer patients undergoing cisplatin chemotherapy referred to Seyed Al-Shohada Hospital in Isfahan will be included in the study and will be randomly divided into 2 groups. In addition to cisplatin chemotherapy, one group will receive Livergol and the other group will receive a placebo. Then the chemotherapy induced peripheral neuropathy score of patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age over 18 years, newly diagnosed cancer and undergoing chemotherapy with cisplatin, have symptoms of peripheral neuropathy after starting chemotherapy and consent to participate in this study. Exclusion criteria include having multiple myeloma, having previous neurological disorders, and having diseases that give rise to peripheral neuropathy (such as diabetes).
Intervention groups
Intervention group: In addition to cisplatin chemotherapy, patients in this group will be treated with Livergol 140 mg tablets 3 times a day for 90 days. Control group: In addition to cisplatin chemotherapy, patients in this group will receive placebo 3 times a day for 90 days.
Main outcome variables
Chemotherapy induced peripheral neuropathy score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N29
Registration date:2021-04-06, 1400/01/17
Registration timing:registered_while_recruiting
Last update:2021-04-06, 1400/01/17
Update count:0
Registration date
2021-04-06, 1400/01/17
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Livergol (silymarin extract) in reducing peripheral neuropathies induced by cisplatin in patients undergoing chemotherapy
Public title
Evaluation of the effect of Livergol in reducing peripheral neuropathies induced by cisplatin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Newly diagnosed cancer and undergoing chemotherapy with cisplatin
Having symptoms of peripheral neuropathy after starting chemotherapy
Consent to participate in this study
Exclusion criteria:
Having multiple myeloma
Having previous neurological disorders
Having diseases that give rise to peripheral neuropathy (such as diabetes)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 60 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the two drugs Livergol and placebo are prepared by the pharmacist with the same color, smell and shape and placed in coded packages and delivered to the patient, and the same instructions are prescribed to the patient. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
Intervention group: In addition to cisplatin chemotherapy, patients in this group will be treated with Livergol 140 mg tablets 3 times a day for 90 days.
Category
Treatment - Drugs
2
Description
Control group: In addition to cisplatin chemotherapy, patients in this group will receive placebo 3 times a day for 90 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed-al-Shohada Hospital of Isfahan
Full name of responsible person
Ali Haji Gholami
Street address
Internal Medicine Department, Al-Zahra Hospital, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
ali_hajigholami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Haji Gholami
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Internal Medicine Department, Al-Zahra Hospital, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
ali_hajigholami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Haji Gholami
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Internal Medicine Department, Al-Zahra Hospital, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
ali_hajigholami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Adele Dadkhah
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Department, Al-Zahra Hospital, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
dadkhah@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD