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Effect of a medium-chain triglyceride (MCT)-Based Ketogenic Dietary Intervention along with high-dose intravenous ascorbic acid among overweight/obese patients with triple-negative breast cancer

Protocol summary

Study aim
We aim to determine the effect of a medium-chain triglyceride-Based ketogenic diet along with high-dose intravenous ascorbic acid for 12 weeks among patients with triple-negative breast cancer.
Design
A controlled, parallel-group, single blinded, randomized, phase 3 clinical trial on 240 patients. A stratified block randomization method using SAS software will be used to create a random sequence.
Settings and conduct
This study is among patients with histologically triple-negative breast cancer referred to the radiotherapy clinic at Emam Reza Hospital in Tabriz. Patients candidate for adjuvant radiation (incomplete pathologic answer after neoadjuvant chemotherapy or unresectable tumor) and who have received breast conservation surgery will be recruited by convenience sampling.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18 to 70 years old, pathologically confirmed early-stage triple-negative subtype, 1–3 positive axillary lymph nodes, histological grades I-III, unilateral cancer, and have a body mass index of 25 kg/m2 and higher Exclusion criteria: serious cardiovascular disease, metabolic defects, abnormal blood indices, use of systemic corticosteroids within one week of trial entry, receipt of chemotherapy within two weeks of trial entry, prior monoclonal antibody therapy within 1 month of trial entry.
Intervention groups
1) A medium-chain triglyceride-based ketogenic diet 2) A medium-chain triglyceride-based ketogenic diet along with high-dose intravenous ascorbic acid 3) High-dose intravenous ascorbic acid along with a regular balanced diet 4) Regular balanced diet
Main outcome variables
Weight, body composition indices, circulating leptin and free fatty acids, serum glucose metabolism, inflammatory, and oxidative stress indices, fatigue, quality of life, depression, anxiety, and radiological response

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161022030424N11
Registration date: 2024-08-06, 1403/05/16
Registration timing: prospective

Last update: 2024-08-06, 1403/05/16
Update count: 0
Registration date
2024-08-06, 1403/05/16
Registrant information
Name
Neda Dolatkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 1928
Email address
dolatkhahn@tbzmed.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a medium-chain triglyceride (MCT)-Based Ketogenic Dietary Intervention along with high-dose intravenous ascorbic acid among overweight/obese patients with triple-negative breast cancer
Public title
Ketogenic diet along with high-dose ascorbic acid in triple-negative breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 70 years old Pathologically confirmed early-stage triple-negative breast cancer subtype 1–3 positive axillary lymph nodes Histological grades I-III Unilateral cancer A body mass index (BMI) of 25 kg/m2 and higher
Exclusion criteria:
Serious cardiovascular disease Pregnancy Cognitive impairment Metabolic defects as a contraindication against ketogenic diet Who are considered unsuitable for the trial by the principal investigator because of abnormal blood indices or other reasons Use of systemic corticosteroids within one week of trial entry Receipt of chemotherapy within two week of trial entry Prior monoclonal antibody therapy within 1 month of trial entry
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
We will use a stratified block randomization method for allocation. The computer-generated code generated using SAS software version 8.01 will be used to create a randomized sequence by a statistician outside the project's research team. Randomization will be stratified based on the pathological lymph node status (negative vs positive), and menopause status. Serially numbered opaque sealed packets will be used to ensure allocation concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding the patients is not feasible in this trial. A trained nutritionist will ban diet-related conversations between assessors and patients during the study. Outcome assessors and the person responsible for statistical analysis will be blinded to the type of interventions received until the end of the study.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Science
Street address
3rd Floor, No. 2, Central Building, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5214698725
Approval date
2024-07-08, 1403/04/18
Ethics committee reference number
IR.TBZMED.REC.1403.282

Health conditions studied

1

Description of health condition studied
Triple negative breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Weight
Timepoint
Weight measurement at the beginning of the study (before the intervention) and the final week of radiotherapy
Method of measurement
InBody 720 Body Composition Analyzer 2004; Biospace Co., Ltd., Seoul, Korea)

2

Description
Lean body mass
Timepoint
Lean body mass measurement at the beginning of the study (before the intervention) and the final week of radiotherapy
Method of measurement
InBody 720 Body Composition Analyzer 2004; Biospace Co., Ltd., Seoul, Korea)

3

Description
Total body fat mass
Timepoint
Total body fat mass measurement at the beginning of the study (before the intervention) and the final week of radiotherapy
Method of measurement
InBody 720 Body Composition Analyzer 2004; Biospace Co., Ltd., Seoul, Korea)

Secondary outcomes

1

Description
Leptin
Timepoint
Serum leptin measurement at the beginning of the study (before the intervention) and the end of the intervention
Method of measurement
Biochemical analysis

2

Description
Free fatty acids
Timepoint
Serum free fatty acids measurement at the beginning of the study (before the intervention) and the end of the intervention
Method of measurement
Biochemical analysis

3

Description
Fasting blood glucose
Timepoint
Serum fasting blood glucose measurement at the beginning of the study (before the intervention) and the end of the intervention
Method of measurement
Biochemical analysis

4

Description
Insulin
Timepoint
Serum insulin measurement at the beginning of the study (before the intervention) and the end of the intervention
Method of measurement
Biochemical analysis

5

Description
High-sensitivity C-reactive protein
Timepoint
Serum high-sensitivity C-reactive protein measurement at the beginning of the study (before the intervention) and the end of the intervention
Method of measurement
Biochemical analysis

6

Description
Total antioxidant capacity
Timepoint
Serum total antioxidant capacity measurement at the beginning of the study (before the intervention) and the end of the intervention
Method of measurement
Biochemical analysis

7

Description
Malondialdehyde
Timepoint
Serum malondialdehyde measurement at the beginning of the study (before the intervention) and the end of the intervention
Method of measurement
Biochemical analysis

8

Description
Fatigue
Timepoint
Fatigue measurement at the beginning of the study (before the intervention) and the end of the intervention
Method of measurement
Brief Fatigue Inventory

9

Description
Depression
Timepoint
Depression measurement at the beginning of the study (before the intervention) and the end of the intervention
Method of measurement
Beck depression inventory-second edition

10

Description
Anxiety
Timepoint
Anxiety measurement at the beginning of the study (before the intervention) and the end of the intervention
Method of measurement
State-Trait Anxiety Inventory

11

Description
Quality of life
Timepoint
Quality of life measurement at the beginning of the study (before the intervention) and the end of the intervention
Method of measurement
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

Intervention groups

1

Description
Intervention group 1: A medium-chain triglyceride-based ketogenic diet [6% of daily energy intake from carbohydrates, 19% from protein, 20% from medium-chain triglyceride, and 55% from fat]. A volume of 500 ml of Norm Life medium chain triglyceride oil from Vanadarou Company will be provided to the patients every two weeks. Medium chain triglyceride oil will be initiated with a low dose and then will be increased daily for one week until it reaches the maximum dosage and finally will be discontinued in a stepwise procedure.
Category
Treatment - Other

2

Description
Intervention group 2: A medium-chain triglyceride-based ketogenic diet along with high-dose intravenous ascorbic acid. High-dose intravenous ascorbic acid will provided a first dose of 25 g of ascorbate one day before planned radiotherapy, and then daily ascorbate infusions of up to 1 g/kg body weight (capped at a total daily dose of 75 g) for 3 days (days 2–4). OSVE-VITAMIN C AMP, equivalent to 500MG/5ML ascorbic acid, will be diluted in 100 ml normal saline 0.9% for injection (25 g ascorbic acid on day 1) or 300 ml normal saline 0.9% (up to 75 g ascorbic acid for days 2–4) instantly before prescription and will be infused into the median cubital vein at 0.5–1 g/min. High-dose intravenous ascorbic acid will be given every 2 weeks afterward until progressive disease or undesirable toxicities happen or a decision by a participant to withdraw from the study.
Category
Treatment - Other

3

Description
Intervention group 3: High-dose intravenous ascorbic acid along with a regular balanced diet [55-60% of daily energy intake from carbohydrate, 15-20% from protein, and 20-25% from fat]
Category
Treatment - Other

4

Description
Control group: Regular balanced diet [55-60% of daily energy intake from carbohydrate, 15-20% from protein, and 20-25% from fat]
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Neda Dolatkhah
Street address
Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5123698574
Phone
+98 41 3336 1928
Email
imamreza@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
3rd Floor, No. 2, Central Building, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5169875632
Phone
+98 41 3335 7311
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Reza Hospital, Faculty of Medicine, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
neda_dolatkhah@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Reza Hospital, Faculty of Medicine, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
neda_dolatkhah@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Reza Hospital, Faculty of Medicine, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
neda_dolatkhah@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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