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RecruitingNot ApplicableNCT05938322

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

194 participants

Start Date

Jun 10, 2024

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

OTHERKetogenic Diet

In the group of intervention is prescribed a ketogenic diet plan characterized by the following composition: carbohydrates \< 30g/day, 1.2g-1.5g protein/kg/day and lipids \> 65%. This diet will be followed during the period of treatment with chemo-radiotherapy (5 weeks)

OTHERStandard Diet

The control group (SD) will follow the Mediterranean diet pattern based on ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%).

Locations(1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Rome, Italy

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NCT05938322

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