The effect of metformin on protecting against chemotherapy-induced neuropathy in breast cancer patients
Design
This double-blind randomized clinical trial is conducted with a control group and parallel groups, phases 3 and 2, on 40 patients.
Settings and conduct
The study setting is the Gynecologic Oncology Ward of Baqaei 2 Hospital, Ahvaz, Iran. The patients are also sampled and transferred to the laboratory unit as a code.
Participants/Inclusion and exclusion criteria
To conduct this study, a group of newly diagnosed cases with breast cancer referred to Baghei 2 Hospital, Ahvaz, Iran, undergoing the paclitaxel chemotherapy regimen, are included. The definitive diagnosis of breast cancer in these people is also made through the biopsy findings.
The exclusion criteria in this study are:
1. Active diabetes or its history
2. The history of neuropathy or nerve damage
3. Anemia
4. The history of chemotherapeutic agent used
5. Hyperthyroidism or thyrotoxicosis
6. The patients with digestive problems who were less likely to tolerate metformin
7. The patients with contraindications for metformin treatment
Intervention groups
Breast cancer patients undergoing paclitaxel chemotherapy
Main outcome variables
Metformin may prevent neuropathy in patients with breast cancer treated with paclitaxel.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151021024645N3
Registration date:2021-11-20, 1400/08/29
Registration timing:registered_while_recruiting
Last update:2021-11-20, 1400/08/29
Update count:0
Registration date
2021-11-20, 1400/08/29
Registrant information
Name
hosein karimpoorian
Name of organization / entity
medical unevirsity of ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 916 603 6991
Email address
karimpoorian.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The application of metformin in protecting chemotherapy-induced neuropathy in patients with breast cancer
Public title
The application of metformin in protecting chemotherapy-induced neuropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients affected with breast cancer, based on the biopsy findings,
Exclusion criteria:
Active diabetic patients or those with a history of diabetes
The history of neuropathy or nerve damage
Anemia
The history of chemotherapeutic agent use
Hyperthyroidism or thyrotoxicosis
The patient with digestive problems who may less likely tolerate metformin
The patients with contraindications for metformin treatment
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization using 2 and 4 blocks (randomly)
Randomization unit: Individual
Randomization tool: Web application or software
Description of allocation concealment: Using opaque sealed envelopes with a random sequence
Blinding (investigator's opinion)
Double blinded
Blinding description
The laboratory collaborators are not aware of the intervention and control people, and the samples are given to them with a code. The patients are also unaware of the potential benefits of using metformin to protect against neuropathy because they have to complete a questionnaire.
Placebo
Not used
Assignment
Parallel
Other design features
The study subjects are divided into two groups, receiving routine chemotherapy. In the intervention group, metformin is used in addition to routine chemotherapy, at the beginning of the study (before the intervention), at the end of cycle 6, and the end of cycle 12.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz jundishapur University of Medical Sciences
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2021-10-17, 1400/07/25
Ethics committee reference number
IR.AJUMS.REC.1400.441
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
2C6Z
ICD-10 code description
Carcinoma of breast, specialised type
Primary outcomes
1
Description
Severity of neuropathy
Timepoint
At the beginning of the study and in cycles 2, 4, 6, 8, 10 and 12
Method of measurement
PNQ questionnaire, CTCAE questionnaire
2
Description
Laboratory parameters
Timepoint
At the beginning of the study (before the intervention), the end of cycle 6 and the end of cycle 12.
Method of measurement
Laboratory evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The drug is metformin, prescribed in the form of three tablets of 500 mg per day (1500 mg per day in total) for three months from the first day of chemotherapy. Due to the availability of the medicine, it is prepared from the best available in the market.
Category
Prevention
2
Description
Control group: This group only uses the paclitaxel chemotherapy regime for three months.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghaei 2 hospital
Full name of responsible person
Dr. Hossein Karimpourian
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3375 0417
Email
Hosseinkarimpourian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadi moghaddam
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
159
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hossein Karimpourian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult Hematology and oncology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3375 0417
Email
Hosseinkarimpourian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hossein Karimpourian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult Hematology and oncology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3375 0417
Email
Hosseinkarimpourian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Daryush Purrahman
Position
Research assistant
Latest degree
Master
Other areas of specialty/work
Hematology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3375 0422
Email
daryushpurrahman@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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of the questionnaire are published in full. Some laboratory results are published.
When the data will become available and for how long
Access is open six months after the article is published.
To whom data/document is available
Given the importance of the study, everyone can have access
Under which criteria data/document could be used
The use of data is only permitted for modeling in a similar study.
From where data/document is obtainable
The data can be accessed by contacting Daryushpurrahman@gmail.com
What processes are involved for a request to access data/document
Mention the purpose of the request and introduce the people who have access to the data.