Evaluation of the preventive effect of metformin on paclitaxel-induced peripheral neuropathy
Design
Two arm parallel group & single blinded phase II randomized clinical trial
Settings and conduct
This study will be conducted on cancer patients referred to radiation oncology department of Namazi hospital in Shiraz in 2019. The case group (n=30) take 500 mg metformin Po Bid during chemotherapy with Paclitaxel (Paclitaxel; 175 mg/m2 IV infusion during 3 hours every 2weeks or 3weeks), and control group (n=30) will not receive any additional medications during chemotherapy. Nerve conduction study (NCS) will be done at the beginning and the end of study for evaluating the change of neuropathy in cases versus controls. The patient will be unaware of medication content (single blinded). Adverse effects of intervention will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with histologically confirmed cancer, stage I – IV; Age = or > 18 years old and < 75 years old; Non-diabetics; Patients scheduled to undergo paclitaxel chemotherapy for cancer; Adequate hepatic and renal functions; ECOG performance status of 0 or 1; Signing the informed consent. Exclusion criteria: Patients with diabetes mellitus; A history of clinically significant hypersensitivity reaction to medications; Patients who are currently using metformin; Metformin induced neuropathy at 12 week
Intervention groups
The cancer patients in the case group will be taken the 500 mg metformin Po Bid during chemotherapy with Paclitaxel. The cancer patients in the control group will not be taken any additional medication during chemotherapy.
Main outcome variables
The primary outcome is the prevention of paclitaxel-induced peripheral neuropathy, and the secondary outcome includes side effects.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190813044526N1
Registration date:2019-09-23, 1398/07/01
Registration timing:prospective
Last update:2019-09-23, 1398/07/01
Update count:0
Registration date
2019-09-23, 1398/07/01
Registrant information
Name
Samineh Sadeghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4320
Email address
sadeghian_s@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-27, 1398/07/05
Expected recruitment end date
2019-12-26, 1398/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of the Preventive Effect of Metformin on Paclitaxel-Induced Peripheral Neuropathy
Public title
The Effect of Metformin on Neuropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Non-diabetic patients with histologically confirmed cancer;
scheduled to undergo paclitaxel chemotherapy for cancer.
Exclusion criteria:
Patients with diabetes mellitus;
A history of clinically significant hypersensitivity reaction to medications;
Pregnancy;
Patients who are currently using metformin;
Metformin induced neuropathy at 12 week
Age
From 18 years old to 75 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this trial, subjects will be randomly assigned to one of two intervention and control groups using the random number table. There are no prerequisites for assigning individuals to groups. The randomization unit is individual. Each participant will have an equal chance of being placed in each group. In this study, blinding is done by the project colleagues and the patient will not know the contents of the drug.randomization with individual randomization unit.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, a single blinding will be performed, the patient will not be aware of the drug content. So, the patient considers it to be part of the treatment process and to control the side effects of chemotherapy.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Faculty of medicine, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71937-11351
Approval date
2019-07-30, 1398/05/08
Ethics committee reference number
IR.SUMS.MED.REC.1398.318
Health conditions studied
1
Description of health condition studied
Drug-induced Peripheral polyneuropathy
ICD-10 code
G62.0
ICD-10 code description
Drug-induced polyneuropathy
Primary outcomes
1
Description
Prevention of paclitaxel-induced peripheral neuropathy
Timepoint
Before and after intervention (week 12)
Method of measurement
Nerve conduction study
Secondary outcomes
1
Description
Side effects
Timepoint
Weekly during intervention course
Method of measurement
Taking a history from the patient
Intervention groups
1
Description
Intervention group: Receiving 500 mg metformin Po Bid during chemotherapy with Paclitaxel
Category
Prevention
2
Description
Control group: Without receiving additional medications during chemotherapy
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Ahmad Mosallaei
Street address
Thirty-Sixth room, Department of radiation oncology, Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
mosalaa@sums.ac.ir
Web page address
http://www.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Deputy of Research, Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Samineh Sadeghian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Forty-second room, Department of radiation oncology, Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
sadeghian_s@sums.ac.ir
Web page address
http://www.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Mosallaei
Position
Full professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Thirty-Sixth room, Department of radiation oncology, Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
mosalaa@sums.ac.ir
Web page address
http://www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samineh Sadeghian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Forty-second room, Department of radiation oncology, Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
sadeghian_s@sums.ac.ir
Web page address
http://www.sums.ac.ir
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
Information about main outcomes of the study
When the data will become available and for how long
Six months after publishing the results
To whom data/document is available
Researchers in universities and scientific and research centers
Under which criteria data/document could be used
In order to improve the treatment of the disease and subsequent research and with the permission of the authors
From where data/document is obtainable
Department of radiation oncology of Shiraz university of medical sciences
What processes are involved for a request to access data/document
Sending the request in writing or by email to the authors