Ketogenic diet along with high-dose ascorbic acid in triple-negative breast cancer

Phase 3

Recruiting

• Conditions: Triple negative breast cancer.; Malignant neoplasm of breast

• Registration Number: IRCT20161022030424N11
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).;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).;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).