NCT05938322 Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers
| NCT ID | NCT05938322 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 194 participants |
| Start Date | 2024-06-10 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 194 participants in total. It began in 2024-06-10 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with locally advanced non-metastatic adenocarcinoma of the rectum undergoing chemoradiation therapy will be assigned to 2 groups: * the intervention group will be prescribed an individualized ketogenic eating plan to be followed throughout the treatment period * the control group will be prescribed a diet therapy plan treatment following the international guidelines of clinical nutrition, also to be followed during treatment
Eligibility 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
Contact & Investigator
Maria Cristina Mele
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT05938322 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05938322 currently recruiting?
Yes, NCT05938322 is actively recruiting participants. Contact the research team at mariacristina.mele@unicatt.it for enrollment information.
Where is the NCT05938322 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05938322 clinical trial?
NCT05938322 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Maria Cristina Mele at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 194 participants.
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