KOMPARC: Ketogenic Diet Compliance in Patients Affected by Locally Advanced Rectal Cancer Patients Who Undergo to Radiotherapy
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ketogenic Diet In the group of intervention is prescribed a ketogenic diet plan. |
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)
|
| 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 |
Other: 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%).
|
Outcome Measures
Primary Outcome Measures
- Adherence to the ketogenic diet [2 months]
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.
Secondary Outcome Measures
- Assessment of fat mass (FM) in the group of patients on ketogenic diet (KD) compared with the control group [2 months]
The assessment will be carried out through the use of an impedance analysis (BIA)
- Evaluation of maintenance of metabolically active mass (BCM) in the group of patients on ketogenic diet (KD) compared with the control group [2 months]
The assessment will be carried out through the use of an impedance analysis (BIA)
- Investigate the impact of BCM maintenance on metabolic, inflammatory, hematologic and endocrine response [2 months]
The assessment will be carried out through blood test analysis
- Evaluation of the correlation between ketogenic diet (KD) and metabolic, inflammatory, hematologic and endocrine response [2 months]
The assessment will be carried out through blood test analysis
- Evaluation of the tolerability to the treatment [2 months]
Radiotherapy interruptions will be evaluated
- Evaluation of the response to the treatment [2 months]
The assessment will be carried out through pelvic MRI analysis, clinical evaluation, and pathological response
- Investigate indices of quality of life [2 months]
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).
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5812