Ketogenic versus Mediterranean-style diet during radiotherapy for rectal cancer
Compliance With Ketogenic Diet in Patients Undergoing Radiotherapy for Pelvic Cancers: a Prospective, Randomized, Mono-centric Study
This study will test whether people with locally advanced rectal cancer can follow a ketogenic eating plan compared with a standard Mediterranean-style diet while receiving neoadjuvant chemoradiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT05938322 on ClinicalTrials.gov |
What this trial studies
Patients with locally advanced, non-metastatic rectal adenocarcinoma scheduled for neoadjuvant radiotherapy are assigned to either an individualized ketogenic diet (carbs <30 g/day, 1.2–1.5 g protein/kg/day, >65% lipids) or a standard diet based on ESPEN/Mediterranean guidelines (45–55% carbs, 15–20% protein, 30–35% lipids). Diet adherence will be measured from patient food diaries, with visits before radiotherapy, once during treatment, and at the end of treatment. Clinical measures including BMI, body composition by bioimpedance, hand-grip strength, and sit-to-stand performance will be recorded, and radiochemotherapy toxicity and compliance will be monitored at routine oncology visits. The primary focus is feasibility and compliance to the dietary plans during the radiochemotherapy period.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed, locally advanced non-metastatic rectal adenocarcinoma who are scheduled for neoadjuvant radiotherapy and can give informed consent.
Not a fit: Patients who are severely malnourished, have metastatic disease, diabetes, are pregnant or lactating, or have major food allergies that prevent the diets are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the ketogenic approach could help maintain nutritional status or muscle mass and improve tolerance to chemoradiation for some patients.
How similar studies have performed: Small clinical and preclinical studies have explored ketogenic diets in cancer with mixed and preliminary results, so this approach is promising but not yet well established in radiotherapy for rectal cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologic confirmation of rectal adenocarcinoma * Locally advanced rectal cancer * Patients undergoing neoadjuvant radiotherapy treatment * Signature of informed consent to the processing of personal data Exclusion Criteria: * Severely malnourished patients according to GLIM (Global Leadership Initiative on Malnutrition) criteria * Patients treated for palliative purposes * Patients with metastatic disease * Diabetes mellitus * Pregnancy or lactation * Significant food allergies that would make the person unable to consume the food provided * Refusal to participate in the proposed clinical trial
Where this trial is running
Rome
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Cristina Mele — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Maria Cristina Mele, MD
- Email: mariacristina.mele@unicatt.it
- Phone: 00390630156772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.