To evaluate the efficacy and safety of adding metformin to chemoradiation of patients with squamous cell carcinoma of hypopharynx, nasopharynx, and larynx
Determination of the efficacy and safety of adding metformin to chemoradiation of patients with squamous cell carcinoma of hypopharynx, nasopharynx, and larynx
Design
Non-randomized clinical trial phase II without controls and without blindness
Settings and conduct
The eligible patients with proven diagnosis of squamous cell carcinoma of hypopharynx, nasopharynx, and larynx referring to radiation oncology department of Namazi hospital in Shiraz will be received radiotherapy (60-70 Gy in 30-35 fractions) with concurrent chemotherapy weekly. Participants (N = 25) will take metformin orally twice daily (1000 mg/day) after eating from 7 to 11 days prior chemoradiotherapy until the end of it. Toxicity score will be assessed weekly according National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). The response criteria in spiral CT scan will be checked 12 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria include non-diabetics (FBS < 125 mg/dl and BS < 140 mg/dl); age equals or less than 18 years old; biopsy-proven squamous cell carcinoma of hypopharynx, nasopharynx, and larynx; performance status < 2.
Exclusion criteria: diabetic patients; simultaneous cancer; pregnancy; distant metastasis; hypersensitivity to metformin; renal failure; liver disease.
Intervention groups
Patients (single group) with squamous cell carcinoma of hypopharynx, nasopharynx and larynx under treatment with concurrent chemoradiation will take metformin orally twice daily (1000 mg/day) during treatment
Main outcome variables
The complete response criteria in spiral CT scan
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191203045594N1
Registration date:2019-12-12, 1398/09/21
Registration timing:prospective
Last update:2019-12-12, 1398/09/21
Update count:0
Registration date
2019-12-12, 1398/09/21
Registrant information
Name
Zeinab Adelpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4320
Email address
adelpourz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-18, 1398/09/27
Expected recruitment end date
2020-03-17, 1398/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the efficacy and safety of adding metformin to chemoradiation of patients with squamous cell carcinoma of hypopharynx, nasopharynx, and larynx
Public title
The effect of metformin on treatment of squamous cell carcinoma of neck
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with biopsy-proven squamous cell carcinoma of hypopharynx, nasopharynx, and larynx
Exclusion criteria:
All patients with distant metastasis
Hypersensitivity to metformin
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
2019-06-26, 1398/04/05
Ethics committee reference number
IR.SUMS.MED.REC.1398.239
Health conditions studied
1
Description of health condition studied
Malignant neoplasm of larynx
ICD-10 code
C32.9
ICD-10 code description
Malignant neoplasm of larynx, unspecified
Primary outcomes
1
Description
The complete response
Timepoint
12 weeks after the intervention
Method of measurement
Spiral CT scan
2
Description
Toxicity
Timepoint
Weekly
Method of measurement
Common Terminology Criteria for Adverse Events (CTCAE)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients with proven diagnosis of squamous cell carcinoma of hypopharynx, nasopharynx, and larynx receiving concurrent chemoradiation will take metformin orally twice daily (1000 mg/day) after eating from 7 to 11 days prior chemoradiotherapy until the end of it
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Shapour Omidvari
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
omidvari@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
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
Zeinab Adelpour
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
adelpourz@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shapour Omidvari
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
omidvari@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zeinab Adelpour
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
adelpourz@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