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CompletedNCT06477341Updated Sep 12, 2025

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

An interventional study of various available nutrition as those contain high protein content as ensure milk in Head and Neck Neoplasms, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by Assiut University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2023, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Head and Neck Neoplasms
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In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 47 is close to the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • 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

Interventions

  • Dietary supplementvarious 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: two years

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Study locations

1 site
  • Reham mohamed
    Asyut, Egypt
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References and documents

Related links

Individual participant data

Plan to share: Yes — when research is publicly puplished

Supporting information: Sap

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06477341
Lead sponsor
Assiut University
Responsible party
Reham Mohamed Aboelela Hassan (resident doctor at oncology department of Assiut university hospital, Assiut University) — Principal investigator
First posted
Jun 27, 2024
Start date
Jan 1, 2023
Primary completion
Sep 1, 2025
Completion
Sep 1, 2025
Last update
Sep 12, 2025

Study contacts

Asmaa Abdehtawab, lecturer
study chair · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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