Ketogenic Diet Compliance in Patients Affected by Locally Advanced Rectal Cancer Patients Who Undergo to Radiotherapy

Rectal Cancer Clinical Trial

— KOMPARC  

Official title:

Ketogenic Diet Compliance in Patients Affected by Locally Advanced Rectal Cancer Patients Who Undergo to Radiotherapy: a Prospective, Randomized, Mono-centric Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05938322
• Other study ID #: 5812
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: July 2025

Study information

• Verified date: July 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Maria Cristina Mele, MD
• Phone: 00390630156772
• Email: mariacristina.mele[@]unicatt.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Some days before the start of radiotherapy there will be the first visit in which patients will be enrolled and placed in one of the following two groups:

• The intervention group (KD) will be prescribed a ketogenic diet therapy plan characterized by the following composition: carbohydrates < 30g/day, 1.2g-1.5g protein/kg/day and lipids > 65%.

• The control group (SD) will be prescribed a nutrition plan based on the Mediterranean diet model according to ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%) There will then be two additional follow-ups for patients: one during the period of therapy and one at the end of therapy.

Compliance with diet therapy treatment (SD vs. KD) will be assessed by analysis of a food diary that the patient will be asked to complete.

During follow-ups it will be assessed:

• BMI and body composition (by bioimpedance analysis)

• Muscle strength and physical performance (by hand grip test and sit-to-stand test) Compliance with and toxicity of radiochemotherapy treatment will be assessed at the radiochemotherapy visits (3 visits during treatment)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 194
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• Ketogenic 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)
• Standard 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

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the ketogenic diet	The primary objective is to assess the adherence to the diet therapy treatment plan (SD vs. KD). It will be verified through a food diary that will be given to the patient during the first visit.; The patients will fill out the questionnaire and return it at future visits.	2 months
Secondary	Assessment of fat mass (FM) in the group of patients on ketogenic diet (KD) compared with the control group	The assessment will be carried out through the use of an impedance analysis (BIA)	2 months
Secondary	Evaluation of maintenance of metabolically active mass (BCM) in the group of patients on ketogenic diet (KD) compared with the control group	The assessment will be carried out through the use of an impedance analysis (BIA)	2 months
Secondary	Investigate the impact of BCM maintenance on metabolic, inflammatory, hematologic and endocrine response	The assessment will be carried out through blood test analysis	2 months
Secondary	Evaluation of the correlation between ketogenic diet (KD) and metabolic, inflammatory, hematologic and endocrine response	The assessment will be carried out through blood test analysis	2 months
Secondary	Evaluation of the tolerability to the treatment	Radiotherapy interruptions will be evaluated	2 months
Secondary	Evaluation of the response to the treatment	The assessment will be carried out through pelvic MRI analysis, clinical evaluation, and pathological response	2 months
Secondary	Investigate indices of quality of life	Investigating patients' quality of life through questionnaires administered at the beginning and at the end of treatments. The questionnaires used are EORT ( European Organisation for Research and Treatment of Cancer) QLQ (quality of life questionnaire)-30, QLQ - CR29 and CAX-24 (cancer cachexia-specific questionnaire), and PRT-20 (quality of life questionnaire for proctitis).	2 months