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

Evaluation of the effect of regular nutrition consult on treatment tolerance and quality of life of patients with head and neck squamous cell carcinoma undergoing radiotherapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240625062249N1
Enrollment
200
Registered
2024-08-22
Start date
2024-09-22
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck squamous cell carcinoma. Squamous cell carcinoma of skin of other and unspecified parts of face

Interventions

Intervention 1: Control group: The nutritional advice of the patient was at the level of nutritional recommendations to reduce nutritional complications related to radiotherapy. Intervention 2: Interv

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahsa Malekahmadi

Tehran University of Medical Sciences

malekahmadimahsa@gmail.com+98 913 125 0467

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026