Protocol summary

Study aim
Determination of Complete Response Rate in intervention group and control group Determination of tumor volume in intervention group and control group Determination of pathological,biological features of tumor in intervention group and control group Determination of IGF1 and Insulin level in intervention group and control group Determination of glucose level in intervention group and control group Determination of serum ketone level in intervention group and control group Determination of quality of life in intervention group and control group
Design
randomised controlled trial
Settings and conduct
We plan to recruit 60 patients with locally advanced and metastatic breast cancer from Shohada-Tajrish hospital in Tehran, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria:patient with neoadjuvant and metastic breast cancer that will undergo chemotherapy for at least 3 months patient accept follow ketogenic diet for 3 months.Karnofsky index >70  18 kg/m2 < BMI <34.5 kg/m2  Age between 18 and 75 years exclusion criteria: Type I diabetes  Pregnancy  Known defects in enzymes necessary for ketogenesis, ketolysis,fatty acid oxidation or gluconeogenesis patient with cardiac or liver or kidney disease
Intervention groups
ketogenic diet will be prescribed for 3 month in intervention group. ketogenic diet contain (5-10% CHO,15-20% Protein, 70 -80% FAT based on 20% MCT from nutricia company). Standard diet will be prescribed for control group. Standard diet contain 55% CHO, 30% FAT and 15% protein.
Main outcome variables
Complete Response Rate IGF1 and Insulin level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171105037259N2
Registration date: 2018-05-21, 1397/02/31
Registration timing: registered_while_recruiting

Last update: 2018-05-21, 1397/02/31
Update count: 0
Registration date
2018-05-21, 1397/02/31
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 395 5647
Email address
khodabakhshia@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-26, 1397/02/06
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ketogenic diet on patients with locally advanced and metastatic breast cancer
Public title
Effect of ketogenic diet on patients with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with locally advanced and metastatic breast cancer (Stage III or IV) that will undergo chemotherapy for at least 3 months; Patients who accept ketogenic diet for 3 months; Between 18 -75 years old; BMI between 18.5 - 35.5; Karnofsky Performance Score more than 70%
Exclusion criteria:
Type I diabetes under Insulin therapy; Patients with liver, kidney or cardiac disease; Congenital metabolic disorders that impair Ketogenic diet such as Gluconeogenesis defect; Pregnancy
Age
From 18 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block Balanced Randomization will be used.
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 Shahid Beheshti University of Medical SCIENCE
Street address
•No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
IR.SBMU.nnftri.Rec.1396.187

Health conditions studied

1

Description of health condition studied
breast cancer
ICD-10 code
C50.91
ICD-10 code description
Malignant neoplasm of breast of unspecified site, female

Primary outcomes

1

Description
Complete response rate
Timepoint
At the baseline and the end of the study
Method of measurement
clinical exam,lab test and imaging

Secondary outcomes

1

Description
Insulin level
Timepoint
0, 45, 90
Method of measurement
Eliza

Intervention groups

1

Description
Intervention group: ketogenic diet، ketogenic diet contain (5-10% CHO,15-20% Protein, 70 -80% FAT based on 20% MCT from nutricia company).
Category
N/A

2

Description
Control group: Standard diet، Standard diet contain 55% CHO, 30% FAT and 15% protein.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Cancer Research center -Shohada-e-Tajrish Hospital
Full name of responsible person
Adeleh khodabakhshi
Street address
Shahrdari Ave,Tajrish Square,Shohada Tajrish Hospital
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 8001
Email
khodabakhshiadeleh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology
Street address
Velenjak Ave.Shahid Beheshti University of Medical Science
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Adeleh Khodabakhshi
Position
PhD candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
•No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 913 395 5647
Email
khodabakhshiadeleh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Adeleh Khodabakhshi
Position
PhD candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
•No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 913 395 5647
Email
khodabakhshiadeleh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Adeleh Khodabakhshi
Position
Phd candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
•No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+91 33955647
Email
khodabakhshiadeleh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
result of study
When the data will become available and for how long
2018
To whom data/document is available
all of them
Under which criteria data/document could be used
khodabakhshiadeleh@yahoo.com
From where data/document is obtainable
khodabakhshiadeleh@yahoo.com
What processes are involved for a request to access data/document
khodabakhshiadeleh@yahoo.com
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