Rectal Cancer
Conditions
Keywords
Rectal Cancer, Ketogenic Diet
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
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)
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%).
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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). |
| Evaluation of the tolerability to the treatment | 2 months | Radiotherapy interruptions will be evaluated |
Countries
Italy
Contacts
Primary ContactMaria Cristina Mele, MD
Outcome results
None listed