Rectal cancer, Ketogenic regimen. Malignant neoplasm of rectum
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Clinical response: T, N stage based on MRI. Timepoint: 6 weeks after the end of radiotherapy. Method of measurement: Doing pelvic MRI. | — |
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Hamedan University of Medical Sciences