Investigating the tolerability of a diet containing CAPRIDIN in patients with rectal cancer
Phase 1
Not yet recruiting
- Conditions
- Rectal cancer, Ketogenic regimen.Malignant neoplasm of rectum
- Registration Number
- IRCT20170211032494N4
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Patients aged 18 to 75 years old
Patients with definitive diagnosis of rectal adenocarcinoma according to histopathology
Patients with a Karnofsky score higher than 70
Non-metastatic patients
Locally advanced patients (T3, T4) N0 or N+
Patients with BMI between 18-34
Exclusion Criteria
Patients with metabolic diseases
Pregnancy
Liver or kidney dysfunction
Receiving neoadjuvant chemotherapy
Patients who have undergone rectal cancer surgery for any reason
Breastfeeding
No previous ketogenic diet
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerability: not interrupting the ketogenic diet for more than 4 consecutive days or 8 non-consecutive days. Timepoint: Every four days for 6 weeks. Method of measurement: Medical history taking.;Complications: reports of gastrointestinal discomfort, nausea, vomiting, lethargy, constipation, diarrhea by the patient. Timepoint: Every week for 6 weeks. Method of measurement: Medical history taking.;Serum ketones: the amount of ketones released in the blood. Timepoint: Before starting the study and every day for 6 weeks. Method of measurement: ketometery.
- Secondary Outcome Measures
Name Time Method Clinical response: T, N stage based on MRI. Timepoint: 6 weeks after the end of radiotherapy. Method of measurement: Doing pelvic MRI.