Determining the effects of a ketogenic diet on the treatment of rectal cancer in non-metastatic patients undergoing radiochemotherapy
Design
The current study will be conducted as a randomized clinical trial. In this study, all patients over 18 years of age with rectal cancer referring to the blood and oncology clinic of Urmia Hospital will be randomly divided into two equal groups with a normal diet and ketogenic diet after obtaining informed consent to enter the study.
Settings and conduct
The current study will be conducted as a randomized clinical trial. In this study, all patients over 18 years of age with rectal cancer referring to the blood and oncology subspecialty clinic of Urmia Hospital will be randomly divided into two equal groups with normal diet and ketogenic diet after obtaining informed consent to enter the study. measured.
Participants/Inclusion and exclusion criteria
People with rectal cancer with biopsy and scan confirmed without evidence of metastasis, the patient's non-cooperation during the treatment
Intervention groups
People with rectal cancer
Main outcome variables
The effect of a ketogenic diet on preventing the progression and regression of cancer in a person with non-metastatic rectal cancer during radio-chemotherapy.
General information
Reason for update
Acronym
CRC
IRCT registration information
IRCT registration number:IRCT20240410061465N1
Registration date:2024-04-14, 1403/01/26
Registration timing:prospective
Last update:2024-04-14, 1403/01/26
Update count:0
Registration date
2024-04-14, 1403/01/26
Registrant information
Name
Hadi Maleki-Kakelar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3348 6165
Email address
maleki.hadi@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of a ketogenic diet on the treatment process of patients with non-metastatic rectal cancer requiring chemoradiotherapy
Public title
Investigating the effect of a ketogenic diet on the treatment process of patients with non-metastatic rectal cancer requiring chemoradiotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with rectal cancer
People with biopsy- and scan-confirmed rectal cancer without evidence of metastasis
Exclusion criteria:
Patient non-cooperation during treatment
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
rectal cancer
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Urmia University of Medical Sciences
Street address
No 1, Secend alley, Rodaki Avenue, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5719161583
Approval date
2024-03-17, 1402/12/27
Ethics committee reference number
IR.UMSU.REC.1402.389
Health conditions studied
1
Description of health condition studied
Rectal cancer, ketogenic diet
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum albumin
Timepoint
The beginning of the study
Method of measurement
Blood Serum
2
Description
Ketone Bodies
Timepoint
The beginning of the study
Method of measurement
Blood Serum
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ketogenic diet
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hadi Maleki-Kakelar
Street address
No 1, Secend alley, Rodaki Avenue, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5719161583
Phone
+98 44 3348 6165
Email
Maleki.hadi@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hadi Maleki-Kakelar
Street address
No 1, Secend alley, Rodaki Avenue, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5719161583
Phone
+98 44 3348 6165
Email
maleki.hadi@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Hadi Maleki-Kakelar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No 1, Secend alley, Rodaki Avenue, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5719161583
Phone
+98 44 3348 6165
Email
Maleki.hadi@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hadi Maleki-Kakelar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No 1, Secend alley, Rodaki Avenue, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5709161583
Phone
009844336165
Email
Maleki.hadi@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hadi Maleki-Kakelar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No 1, Secend alley, Rodaki Avenue, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5719161583
Phone
+98 44 3348 6165
Email
Maleki.hadi@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not 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
Part of the data and information related to the main outcome can be shared.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Your data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
It can be used concerning the source
From where data/document is obtainable
Urmia University of Medical Sciences and Research Director
What processes are involved for a request to access data/document
The request is sent to the vice president of research and technology, and they correspond with the person in charge, and it can be reviewed in 2 weeks or less.