Evaluation of the effect of nutrition consult in patients with head and neck squamous cell carcinoma undergoing radiotherapy

Phase 3

Conditions: head and neck squamous cell carcinoma.
C44.32
Squamous cell carcinoma of skin of other and unspecified parts of face

Registration Number: IRCT20240625062249N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 200

Inclusion Criteria

Patients who have been diagnosed with head and neck SCC cancer in T2-T4 stage along with lymph node involvement and are undergoing adjuvant or radical radiotherapy based on the radio-oncologist's diagnosis.
Adult patients over 18 years old
Patients on oral nutrition.

Exclusion Criteria

People who receive enteral or parenteral nutrition before or during the study
Patients with uncontrolled acute underlying diseases such as kidney failure and liver failure (high serum levels of urea and creatinine and decrease in GFR, increase in liver enzymes ALT, AST, ALP)
receiving any other supportive treatment
Patients who die during radiotherapy
Patients who do not continue the study for any reason.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight. Timepoint: Before the intervention and every two weeks until the end of the intervention. Method of measurement: scales.;Body mass index. Timepoint: Before the intervention and every two weeks until the end of the intervention. Method of measurement: formula.;Mid arm circumference. Timepoint: Before the intervention and every two weeks until the end of the intervention. Method of measurement: tape measure.;Calf circumferences. Timepoint: Before the intervention and every two weeks until the end of the intervention. Method of measurement: tape measure.;EORTC QLQ-C?? score. Timepoint: The beginning and end of the intervention. Method of measurement: questionnaire.;PG-SGA score. Timepoint: The beginning and end of the intervention. Method of measurement: questionnaire.

Secondary Outcome Measures

Name	Time	Method
Complete blood count (CBC) measurement. Timepoint: Before and at the end of the intervention. Method of measurement: patient file.;Serum albumin. Timepoint: Before and at the end of the intervention. Method of measurement: Autoanalyzer device (spectrophotometry method).;Total protein. Timepoint: Before and at the end of the intervention. Method of measurement: Autoanalyzer device (spectrophotometry method).;The level of electrolytes. Timepoint: Before and at the end of the intervention. Method of measurement: spectrophotometry.;Local recurrence rate. Timepoint: at the end of the intervention. Method of measurement: Radiography.;Two-year disease-free survival. Timepoint: Two years after the intervention. Method of measurement: patient file.;Treatment tolerance (finishing the course of radiotherapy without interruption due to physical weakness). Timepoint: at the end of the intervention. Method of measurement: patient file.