Compliance With Ketogenic Diet in Patients Undergoing Radiotherapy for Pelvic Cancers: a Prospective, Randomized, Mono-centric Study
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Histologic confirmation of rectal adenocarcinoma
• Locally advanced rectal cancer
• Patients undergoing neoadjuvant radiotherapy treatment
• Signature of informed consent to the processing of personal data
Locations
Other Locations
Italy
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
RECRUITING
Rome
Contact Information
Primary
Maria Cristina Mele, MD
mariacristina.mele@unicatt.it
00390630156772
Time Frame
Start Date: 2024-06-10
Estimated Completion Date: 2027-12
Participants
Target number of participants: 194
Treatments
Experimental: Ketogenic Diet
In the group of intervention is prescribed a ketogenic diet plan.
Active_comparator: Standard Diet
The control group (SD) will follow the Mediterranean diet pattern based on ESPEN (European Society of Parenteral and Enteral Nutrition) guidelines
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS