Determining of the adjuvant ketogenic diet effect on therapeutic outcomes in metastatic colorectal cancer patients
Design
This randomized- parallel and open lable clinical trial study (phase 3) will be conducted on 42 metastatic colorectal cancer patients. Patients will be divided into ketogenic diet and control groups using block randomization method.
Settings and conduct
In this randomized- parallel and open lable clinical trial study, 42 metastatic colorectal cancer patients referred to oncology department of Urmia Imam Khomeini hospital will be enrolled. Patients in the intervention group will be received a ketogenic diet in addition to the standard chemotherapy protocol. The standard chemotherapy protocol will be implemented in the control group.
Participants/Inclusion and exclusion criteria
In this study, patients over 18 years of age with metastatic colorectal cancer will be included. Patients with lipid metabolism disorders such as carnitine deficiency, patients with liver failure, metastatic liver tissue more than 50%, a history of gastric and pancreatic surgery, renal cell carcinoma, type 1 diabetes won't be included.
Intervention groups
Patients in the intervention group will receive a ketogenic diet in addition to the standard chemotherapy protocol. The standard chemotherapy protocol will be implemented in the control group.
Main outcome variables
Response to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210919052515N2
Registration date:2021-11-09, 1400/08/18
Registration timing:registered_while_recruiting
Last update:2021-11-09, 1400/08/18
Update count:0
Registration date
2021-11-09, 1400/08/18
Registrant information
Name
Naser Masoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3337 9924
Email address
masoudi.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the adjuvant ketogenic diet effect on therapeutic outcomes in metastatic colorectal cancer patients
Public title
Adjuvant ketogenic diet and metastatic colorectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with stage 4 of colorectal cancer
Age over 18 years
Exclusion criteria:
Lipid metabolism disorders such as carnitine deficiency
Patients with liver failure
Metastasis to more than 50% in liver tissue
History of gastric and pancreatic surgeries
Renal cell carcinoma
Type 1 diabetes
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and control groups using block randomization method. According to the total sample size (42 patients), 7 blocks of size 6 will be considered. (A: intervention group and B: control group). So that the all possible combinations of AAABBB will be listed. Then each combination will be given a number of one to seven. A number will be selected randomly for determination of one of the possible combinations.
The randomization process will be continued until the last combination is enrolled. Patients will be divided into two groups according to the order of selected blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Imam Khomeini Hospital, Ershad Ave, Modarres Blvd
City
Urmia
Province
West Azarbaijan
Postal code
57157 81351
Approval date
2021-07-14, 1400/04/23
Ethics committee reference number
IR.UMSU.REC.1400.140
Health conditions studied
1
Description of health condition studied
Colon cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
Primary outcomes
1
Description
Response to treatment including primary tumor and metastasis size before and after the intervention
Intervention group: Patients will be received the ketogenic diet for three months in addition to the standard chemotherapy protocol. The ketogenic diet is a low-carb, high-fat diet. The ratio of macronutrients in this diet: 75% fat, 15 to 20% protein, 5 to 10% carbohydrates. The nutritionist will explain to the patients about the diet, then the manuals of this diet will be provided to patients. Patients will be followed by telephone for diet compliance.
Category
Treatment - Other
2
Description
Control group: In the control group, only the standard chemotherapy protocol will be implemented for patients.