Assessment of the adjuvant ketogenic diet effect on the therapeutic outcomes of metastatic breast cancer patients
Design
This randomized- parallel and open-label clinical trial study (phase 3) will be conducted on 42 metastatic breast cancer patient. Patients will be divided into ketogenic diet and control groups using the block randomization method.
Settings and conduct
In this randomized- parallel and open-label clinical trial study, 42 metastatic breast cancer patients referred to the 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 breast 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 surgeries, renal cell carcinoma, and type 1 diabetes will be excluded.
Intervention groups
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.
Main outcome variables
Primary tumor size and the metastasis; Vascular endothelium growth factor expression (VEGF); Ketone bodies; Serum albumin; CRP; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210919052515N1
Registration date:2021-10-22, 1400/07/30
Registration timing:prospective
Last update:2021-10-22, 1400/07/30
Update count:0
Registration date
2021-10-22, 1400/07/30
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
2021-11-22, 1400/09/01
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 the therapeutic outcomes of metastatic breast cancer patients
Public title
The ketogenic diet effect in treatment of metastatic breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Metastatic breast cancer patients
Age over 18 years
Exclusion criteria:
Lipid metabolism disorders such as carnitine deficiency
Patients with liver failure
Metastasis more than 50% of liver tissue
History of gastric and pancreatic surgeries
Renal cell carcinoma
Type 1 diabetes
Age
From 18 years old
Gender
Female
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 the block randomization method. According to the total sample size (42 patients), 7 blocks of 6 will be considered. (A: intervention group and B: control group). so that all possible combinations of AAA BBB will be listed. Then each combination will be given a number of one to seven. A number will be selected randomly for the 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
Urmia University of Medical Sciences, Resalat Ave, Urmia, Iran.
Breast cancer-specific quality of life questionnaire (QLQ-BR 23)
Intervention groups
1
Description
Intervention group: Patients will be received the ketogenic diet for three months in addition to the standard chemotherapy protocol. Manuals of this diet will be provided to patients.
Category
Treatment - Other
2
Description
Control group: In the control group, only the standard chemotherapy protocol will be implemented for patients.