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Investigating the tolerability of a diet containing CAPRIDIN in patients with rectal cancer

Investigating the tolerability of the diet containing CAPRIDIN in patients with rectal cancer undergoing chemoradiotherapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170211032494N4
Enrollment
20
Registered
2023-08-15
Start date
2023-08-23
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer, Ketogenic regimen. Malignant neoplasm of rectum

Interventions

Intervention 1: Patients who take 30 cc of CAPRIDIN fasting on average for 6 weeks in addition to the standard rectal cancer treatment. Capridin is a product of HealthWeX (Canada) that contains medium

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

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

MeasureTime frame
Clinical response: T, N stage based on MRI. Timepoint: 6 weeks after the end of radiotherapy. Method of measurement: Doing pelvic MRI.

Primary

MeasureTime 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

Public ContactReyhaneh Bayani

Hamedan University of Medical Sciences

r.bayani@umsha.ac.ir+98 21 6694 8679

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026