Clinical trial NCT05938322: Ketogenic Diet Compliance in Patients Affected by Locally Advanced Rectal Cancer Patients Who Undergo to Radiotherapy
Official title: Ketogenic Diet Compliance in Patients Affected by Locally Advanced Rectal Cancer Patients Who Undergo to Radiotherapy: a Prospective, Randomized, Mono-centric Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Cancer
Keywords: Rectal Cancer
Ketogenic Diet
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)

Eligibility 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

Primary outcomes:
measure: Adherence to the ketogenic diet
timeFrame: 2 months
Secondary outcomes:
measure: Assessment of fat mass (FM) in the group of patients on ketogenic diet (KD) compared with the control group
timeFrame: 2 months
measure: Evaluation of maintenance of metabolically active mass (BCM) in the group of patients on ketogenic diet (KD) compared with the control group
timeFrame: 2 months
measure: Investigate the impact of BCM maintenance on metabolic, inflammatory, hematologic and endocrine response
timeFrame: 2 months
measure: Evaluation of the correlation between ketogenic diet (KD) and metabolic, inflammatory, hematologic and endocrine response
timeFrame: 2 months
measure: Evaluation of the tolerability to the treatment
timeFrame: 2 months
measure: Evaluation of the response to the treatment
timeFrame: 2 months
measure: Investigate indices of quality of life
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References: