In this quasi-experimental study is a double blind, in order to investigate the protective effect of melatonin radiation, 60 patients ranging in age from 40 to 60 years of age and have the same radiation dose and regimen of chemotherapy and surgery is still not done, the study data are. Patients selected for the study protocol for the regime fu-5 350mg / m2 plus leucovorin 20mg / m2, which first group of one to five days from 23 to 28 chemotherapy treatment and in total 28 radiotherapy day and an hour daily for 5 days per week before radiation therapy received 20 mg of melatonin and the second group one hour daily for 5 days per week before radiation therapy of 20 mg receive wholemeal flour. Blood samples taken before treatment and after treatment and the number of platelets be counted and compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021626586N1
Registration date:2016-03-03, 1394/12/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-03, 1394/12/13
Registrant information
Name
Nasim Kouhi Habibi Dehkordi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
n.kouhi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-18, 1395/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radioprotective effect of melatonin on preventing of cancer-related thrombocytopenia in patient with rectal cancer
Public title
Radioprotective effect of melatonin in patient with rectal cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 60 patients with rectal cancer; aged 40 to 60 years with radiotherapy and chemotherapy same regime that still have not done surgery Exclusion criteria: patients with autoimmune diseases (purpura); von Willebrand's disease; patients that of aspirin drugs; sulfadiazine; daunorubicin use; individuals who previously had chemotherapy or radiotherapy; people who have a history of depression or suicidal feeling
Age
From 40 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol-Gang afrooz Street
City
Babol
Postal code
Approval date
2015-09-08, 1394/06/17
Ethics committee reference number
UBABOL.REC.1394.154
Health conditions studied
1
Description of health condition studied
rectal cancer
ICD-10 code
D12.8
ICD-10 code description
Benign neoplasm: Rectum
2
Description of health condition studied
radiation injury
ICD-10 code
W88
ICD-10 code description
Exposure to ionizing radiation
Primary outcomes
1
Description
thrombocytopenia
Timepoint
before beginning treatment and at the end of treatment
Method of measurement
CBC
Secondary outcomes
1
Description
thrombocytopenia
Timepoint
before beginning treatment and at the end of treatment
Method of measurement
CBC
Intervention groups
1
Description
Melatonin capsules containing 20 mg daily administered 1 hour before radiation therapy 5 days a week for 28 days
Category
Prevention
2
Description
Administration of a capsule containing 20 mg per day 5 days per week wholemeal flour 1 hour before radiation therapy for 28 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajai Hospital of Babolsar
Full name of responsible person
Dr. Ali Shabestani Monfared
Street address
Shilat Square, Babolsar
City
Babolsar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Aliakbar Moghadamnia
Street address
Deputy of research and technology, Babol University of Medical Sciences, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nasim Kouhi Habibi Dehkordi
Position
Msc of radiationbiology
Other areas of specialty/work
Street address
Medical School, Babol University of Medical Sciences, Babol
City
Babol
Postal code
Phone
+98 11 3219 9592
Fax
Email
n.kouhi@mubabol.ac.irkouhi.nasim@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Shabestani Monfared
Position
PhD in Medical Physics
Other areas of specialty/work
Street address
Department of Biophysics, Babol University of Medical Sciences, Babol
City
Babol
Postal code
Phone
+98 11 3219 9592
Fax
Email
Monfared1345@gmail.com Monfared_ali@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nasim Kouhi Habibi Dehkordi
Position
Msc of Radiationbiology
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Babol
City
Babol
Postal code
Phone
00
Fax
Email
kouhi.nasim@gmail.comn.kouhi@mubabol.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)