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NCT05938322Recruiting

Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers

Compliance With Ketogenic Diet in Patients Undergoing Radiotherapy for Pelvic Cancers: a Prospective, Randomized, Mono-centric Study

Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
194 (estimated)
First submitted
12 Jun 2023
Start date
10 Jun 2024
Primary completion date
Dec 2026
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT05938322

What you commit to

  • Study type: Interventional
  • Planned participants: 194
  • From 10 Jun 2024 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with metastatic disease
  • Diabetes mellitus
  • Significant food allergies that would make the person unable to consume the food provided

Other

  • Severely malnourished patients according to GLIM (Global Leadership Initiative on Malnutrition) criteria
  • Patients treated for palliative purposes
  • Pregnancy or lactation
  • Refusal to participate in the proposed clinical trial

Who the study is looking for

  • Histologic confirmation of rectal adenocarcinoma
  • Locally advanced rectal cancer
  • Patients undergoing neoadjuvant radiotherapy treatment
  • Signature of informed consent to the processing of personal data

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.