Head and Neck NeoplasmsNCT06477341
The Effect of Active Nutritional Support On Quality Of Life In Patients With Head And Neck Cancer Receiving Radiotherapy
A study testing various available nutrition as those contain high protein content as ensure milk in people with Head and Neck Neoplasms, run by Assiut University at 1 site in Egypt.
Trial summary
note effect of appropriate nutrition on head and neck cancer patients receiving radiotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- various available nutrition as those contain high protein content as ensure milk
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Advanced and Metastatic head and neck cancer patients
- head and neck cancer patients treated with chemotherapy only
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Head and Neck Neoplasms
- Being tested
- various available nutrition as those contain high protein content as ensure milk
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
various available nutrition as those contain high protein content as ensure milkDietary supplement
note effect with usually prescribed suitable oral and parenteral nutrition for head and neck cancers receiving radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | patients of head and neck cancer receiving radiotherapy , who did not receive any nutritional support during radiotherapy |
| nutritional support grouped | Active comparator | patients of head and neck cancer receiving radiotherapy , who receive any nutritional support during radiotherapy whether oral or intravenous like dipeptivine for mucositis Receives: Dietary Supplement: various available nutrition as those contain high protein content as ensure milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Jan 2023
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mohamed Aboelela Hassan, Assiut University
- Investigators
- Asmaa Abdehtawab, lecturer, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477341
- Sponsor's protocol ID
- RMAHassan
- Status last verified
- Sep 2025
- First submitted
- 26 Mar 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: when research is publicly puplished
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Active Nutritional Support On The Incidence Of Mucositis And Quality Of Life In Patients With Head And Neck Cancer Receiving Radiotherapy
- ClinicalTrials.gov ID
- NCT06477341
- Acronym / sponsor ID
- RMAHassan
- Conditions
- Head and Neck Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
note effect of appropriate nutrition on head and neck cancer patients receiving radiotherapy
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –patients of head and neck cancer receiving radiotherapy , who did not receive any nutritional support during radiotherapy |
| nutritional support grouped | Active comparator | Dietary Supplement: various available nutrition as those contain high protein content as ensure milkpatients of head and neck cancer receiving radiotherapy , who receive any nutritional support during radiotherapy whether oral or intravenous like dipeptivine for mucositis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Advanced and Metastatic head and neck cancer patients
- head and neck cancer patients treated with chemotherapy only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| various available nutrition as those contain high protein content as ensure milknote effect with usually prescribed suitable oral and parenteral nutrition for head and neck cancers receiving radiotherapy | Dietary supplement | nutritional support grouped |
Primary outcome
nutritional status of patients
Time frame: two years
Follow up improvement by evaluating weight in kg and height in meters to calculate body mass index in kg / m^2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. when research is publicly puplished
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asmaa Abdehtawab, lecturer study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing various available nutrition as those contain high protein content as ensure milk in people with Head and Neck Neoplasms, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nutritional status of patients (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.