Study on the safety of modified MCT ketogenic diet and standard therapy combination therapy for colorectal cancer patients
Phase 2
Recruiting
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000044132
- Lead Sponsor
- Toho University Omori Medical Center, Department of Nutrition Therapy Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1. Weight loss of 5% or more has been observed in the last 3 months. 2. Highly advanced example (Exclusion example) When there is liver metastasis, deterioration of liver function, jaundice, and ascites. (Exclusion example) When there is lung metastasis and there are clinical symptoms such as pleural effusion and respiratory distress. However, bone metastases and brain metastases are not excluded. 3. If you have a history of ileus or peritoneal dissemination.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Presence or absence of diarrhea or allergic symptoms b. Dehydration, symptomatological hypoglycemia, excessive ketosis, gastrointestinal symptoms Nutritional status (body weight, body composition analysis using In Body (BIA), serum albumin, serum cholinesterase, serum transthyretin, CRP), QOL score (EORTCQLQ-CR38 Japanese version, POMS2 Japanese version)
- Secondary Outcome Measures
Name Time Method Response rate, pathological control rate, surgical transition rate, transition of tumor markers (including serum anti-p53 antibody titer), PET scan in the clinical range, blood glucose and ketone body measurement using FreeStyle Libre outside the hospital for those who wish Give guidance. In addition, for possible cases, serum and urinary ketone bodies and urinary 8-OHdG will be measured.