The Effect of Active Nutritional Support On Quality Of Life In Patients With Head And Neck Cancer Receiving Radiotherapy

The Effect of Active Nutritional Support On The Incidence Of Mucositis And Quality Of Life In Patients With Head And Neck Cancer Receiving Radiotherapy

note effect of appropriate nutrition on head and neck cancer patients receiving radiotherapy

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Dietary supplement: various available nutrition as those contain high protein content as ensure milk

Detailed Description

Head and neck cancer (HNC) is the sixth most common cancer worldwide with more than half a million new cases diagnosed each year . Because of the limitations imposed by the complicated anatomical structure of the head and neck to the operation, radiotherapy (RT) has become the main treatment method for HNC. However, damage to the normal tissue surrounding the tumor is inevitable. The most common manifestations of injury caused by RT are mucositis with the dry mouth, loss of taste, and dysphagia. The severe dysphagia leads to a definitive total impossibility of eating through the mouth in 20-30% of patients. Radiation-induced oral mucositis (RIOM) is a common side effect after radiotherapy (RT) in head and neck cancer (HNC) patients. RIOM patients with severe pain have difficulty in eating, which increases the incidence of malnutrition and affects patients' quality of life and the process of RT.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt
    • Reham mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• head and neck cancer patients with age >18
• Newly diagnosed head and neck cancer patients
• histological proven HNC cancer
• head and neck cancer patients treated with radiotherapy or chemo radiotherapy

Exclusion Criteria:

• Advanced and Metastatic head and neck cancer patients
• head and neck cancer patients treated with chemotherapy only

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; patients of head and neck cancer receiving radiotherapy , who did not receive any nutritional support during radiotherapy
Active Comparator: nutritional support grouped; patients of head and neck cancer receiving radiotherapy , who receive any nutritional support during radiotherapy whether oral or intravenous like dipeptivine for mucositis	Dietary supplement: various available nutrition as those contain high protein content as ensure milk; note effect with usually prescribed suitable oral and parenteral nutrition for head and neck cancers receiving radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nutritional status of patients	Follow up improvement by evaluating weight in kg and height in meters to calculate body mass index in kg / m^2	two years

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Asmaa Abdehtawab, lecturer, Assiut University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: RMAHassan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: when research is publicly puplished
• IPD Sharing Time Frame: will be available after two years and used whenever it needed
• IPD Sharing Access Criteria: at scientific research magazines
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No