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THE EFFECT OF CITRUS SINENSIS PEEL GEL ON RADIATION-INDUCED ORAL MUCOSITIS IN HEAD AND NECK CANCER PATIENTS (RANDOMIZED CONTROLLED TRIAL)

NCT ID NCT07813923

NEW Sponsor: Alexandria University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

Summary

This randomized controlled clinical trial aims to evaluate the efficacy of Citrus sinensis peel extract gel in the treatment of radiation-induced oral mucositis in head and neck cancer patients. Thirty adult patients with head and neck cancer who develop oral mucositis during radiotherapy will be randomly allocated into two parallel groups. The intervention group will receive Citrus sinensis peel extract gel, while the control group will receive conventional supportive treatment. Clinical outcomes will be evaluated at baseline, 3 weeks, and 6 weeks, including pain intensity and severity of oral mucositis. Salivary total antioxidant capacity will be assessed at baseline and after 6 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients undergoing radiotherapy for head and neck cancer as postoperative (adjuvant) therapy or definitive therapy. * Patients between 18-50 years. * Both males and females. * Patients whose radiotherapy treatment planned dose is 50 Gy or above 8 * Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy. * Patients who are clinically diagnosed with oral mucositis (WHO grade ≥1). Exclusion Criteria: * Smokers, due to impaired mucosal healing and increased inflammation * Pregnant and lactating women * Patients with poor oral hygiene * Use of systemic or topical mucositis treatments within the past 7 days * Patients allergic to orange * Patients allergic to citrus peel or gel formulation components * Patients with systemic diseases (e.g., hypertension, diabetes, cardic diseases etc.) * Patients who have other oral lesions not related to mucositis (e.g., herpetic ulcers, candidiasis)

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced oral mucositis head and neck cancer Head and Neck Neoplasms stomatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck cancer Radiation-induced oral mucositis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • outpatient clinic of the Department of Clinical Oncology, Faculty of Medicine

    Alexandria, Alexandria Governorate, 11553, Egypt

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