Determining the effect of Famotidine as a Radio-protector in reducing the blood side effects of chemo-radiotherapy for esophageal and cardiac cancers
Design
Clinical trial with control group, with parallel group, single blind, randomized, phase 3 on 60 patients. Patients will be divided into intervention and control groups using random blocks (volume of 4 blocks each).
Settings and conduct
Thirty patients will receive famotidine tablets at random and 30 will be studied without taking the pill. Each oral tablet of famotidine will be given once a day 4 hours before chemoradiotherapy. Patients will receive 28 sessions of chemoradiotherapy daily, 5 days a week. Acute complications of radiotherapy will be monitored weekly during the radiotherapy period with a weekly CBC diff check, which is routinely checked in all patients undergoing chemoradiotherapy. The tests will be performed in the laboratory of Valiasr Hospital in Zanjan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients with non-metastatic esophageal cancer and non-metastatic cardiac cancer aged 30 to 75 years who are candidates for chemo radiotherapy and do not receive PPIs and other H2-blocker antagonists.
Exclusion criteria: patients who die during the project. Patients who are unable to continue treatment due to the severity of treatment complications. Patients with kidney disease who are unable to receive famotidine. Need to use PPI family drugs during the treatment process.
Intervention groups
30 patients with esophageal and cardiac cancer receiving famotidine concomitantly with chemo-radiotherapy and 30 patients receiving placebo with concomitant chemo-radiotherapy
Main outcome variables
Hematologic complications of chemoradiotherapy of esophageal and cardiac cancers including lymphocytopenia, granulocytopenia, thrombocytopenia, anemia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170728035349N1
Registration date:2020-08-19, 1399/05/29
Registration timing:prospective
Last update:2020-08-19, 1399/05/29
Update count:0
Registration date
2020-08-19, 1399/05/29
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 9443
Email address
zhkarimi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the radioprotective effects of famotidine in reducing the hematologic complications of esophageal and cardiac cancers chemoradiation.
Public title
Evaluation of the effect of Famotidine in esophageal and cardiac cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with non-metastatic esophageal cancer and non-metastatic cardiac cancer aged 30 to 75 years who are candidates for radiotherapy and do not receive PPIs and other H2-blocker antagonists.
Aged 30 to 75 years old
Being candidates for chemo radiotherapy
Do not receive PPIs and other H2-blocker antagonists.
Exclusion criteria:
Patients who die during the project.
Patients who are unable to continue treatment due to the severity of treatment complications.
Patients who are unable to continue treatment due to the severity of treatment complications.
Need to use PPI family drugs during the treatment process
Age
From 30 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; participants are assigned in study groups by block randomization method. The blocks sample size is 4; two persons in intervention and two persons in control group. Different possible blocks are randomly selected to achieve final sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participant do not know the intervention they receive.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Radiotherapy Department, Valiasr Hospital, Sheikh Fazlollah Nouri Highway, Zanjan City
City
Zanjan
Province
Zanjan
Postal code
45139-56183
Approval date
2020-08-03, 1399/05/13
Ethics committee reference number
IR.ZUMS.REC.1399.158
Health conditions studied
1
Description of health condition studied
Esopageal Cancer
ICD-10 code
C15
ICD-10 code description
Malignant neoplasm of esophagus
2
Description of health condition studied
Cardia Cancer
ICD-10 code
C16.0
ICD-10 code description
Malignant neoplasm of cardia
Primary outcomes
1
Description
Blood Complications Chemo Radiotherapy for esophageal and cardiac cancers
Timepoint
Acute blood complications of chemo radiation weekly during radiotherapy with weekly CBC diff check for 5 weeks
Method of measurement
CBC diff blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients, 28 days of famotidine with 28 sessions of radiotherapy
Category
Prevention
2
Description
Control group: 30 patients take placebo for 28 days concurrent with radiotherapy sessions
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Valiaser Hospital
Full name of responsible person
Zhaleh Karimimoghaddam
Street address
Zanjan Valiaser Hospital
City
Zanjan
Province
Zanjan
Postal code
45139-56183
Phone
+98 24 3302 3754
Email
zhkarimi@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mazyar Peyda
Street address
Zanjan University of Medical Sciences, Gavazang road
City
Zanjan
Province
Zanjan
Postal code
45139-56183
Phone
+98 24 3315 6142
Email
mazyarpeyda@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Zhaleh Karimimoghaddam
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Zanjan University of Medical Sciences ,Valiasr Hospital, ِDepartment of Radiotherapy
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Phone
+98 24 3302 3754
Email
zhkarimi@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zhaleh Karimimoghaddam
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Oncology
Street address
Zanjan University of Medical Sciences Valiasr Hospital Department of Radiotherapy
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Phone
+98 24 3302 3754
Email
zhkarimi@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zhaleh Karimimoghaddam
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Zanjan University of Medical Sciences Valiasr Hospital Department of Radiotherapy
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Phone
+98 24 3302 3754
Email
zhkarimi@zums.ac.ir
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