Radiation-Induced Oral MucositisRICE-MUCNCT07242859
Rice Bran Supplementation for Radiation-Induced Oral Mucositis in Head and Neck Cancer
A study testing rice bran in people with Radiation-Induced Oral Mucositis and Head &Amp; Neck Cancer, run by Christina Milad Lobos at 1 site in Egypt.
Trial summary
This study aims to find out if taking rice bran supplements can help reduce the painful mouth sores (oral mucositis) that often occur in patients with head and neck cancer who receive radiation therapy. The trial will include adult patients undergoing radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation-Induced Oral Mucositis, Head &Amp; Neck Cancer, Head &Amp; Neck Squamous Cell Carcinoma
- What is being tested?
- rice bran
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or female patients of age 18 years old tor more
- Patients with squamous cell carcinomas without metastases of other non-head and non-neck tumors.
- Patients undergoing radiotherapy with an ECOG performance status of 0, 1, or 2
- Patients who will receive IMRT delivered as radical or adjuvant therapy with or without concurrent chemotherapy
- Ready to provide written informed consent
Who cannot join
- Receiving any other approved or investigational anti-cancer agent than those specified in this study.
- Pregnant or breastfeeding female patients
- Patients who have oral lesions unrelated to treatment or cancer,
- Patients who are on drugs that could cause oral lesions or are using anticoagulants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Rice Bran on Radiation-Induced Oral Mucositis in Patients With Head/Neck Cancer and Its Impact on the Quality of Life
This study aims to find out if taking rice bran supplements can help reduce the painful mouth sores (oral mucositis) that often occur in patients with head and neck cancer who receive radiation therapy. The trial will include adult patients undergoing radiation treatment. Participants will be given rice bran supplements during their therapy to see if it can lessen these side effects and improve their overall quality of life.
Read the detailed description
Radiation-induced oral mucositis is a common and debilitating side effect experienced by patients undergoing radiation therapy for head and neck cancer. This condition causes painful inflammation and ulceration of the mucous membranes in the mouth, significantly impacting patients' ability to eat, speak, and maintain oral hygiene, thereby reducing their quality of life.
This study investigates the therapeutic potential of rice bran, a natural byproduct of rice milling rich in antioxidants and anti-inflammatory compounds, as a dietary supplement to mitigate the severity of oral mucositis. Participants will be adult patients diagnosed with head and neck cancer who are scheduled to receive radiation therapy.
The intervention involves administering rice bran supplements concurrently with radiation treatment. The study aims to evaluate the effects of rice bran on the incidence, duration, and severity of oral mucositis, as well as its overall impact on patients' quality of life during and after treatment.
By assessing clinical outcomes and patient-reported measures, this trial seeks to provide evidence on whether rice bran can serve as an effective, low-cost, and accessible supportive care option for managing radiation-induced oral mucositis.
- Conditions
- Radiation-Induced Oral Mucositis, Head &Amp; Neck Cancer, Head &Amp; Neck Squamous Cell Carcinoma
- Being tested
- rice bran
- Keywords
- Radiation-Induced Oral Mucositis, Oral Mucositis, Head and Neck Cancer, Rice Bran, Dietary Supplement, Radiation Therapy Side Effects, Quality of Life, Supportive Care, Antioxidants, Cancer Treatment Support
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rice branDietary supplement
Also called Oryza
Participants in the intervention group will receive a standardized dose of rice bran supplement administered orally each day throughout the course of their radiation therapy. The rice bran used is a natural dietary supplement rich in antioxidants and anti-inflammatory compounds, aimed at reducing the severity and duration of radiation-induced oral mucositis in patients with head and neck cancer.
| Study group | Role | What they receive |
|---|---|---|
| Rice Bran Supplement Group | Experimental | Participants in this group will receive rice bran supplements daily during their radiation therapy. The supplement is intended to reduce the severity of oral mucositis and improve quality of life. Receives: Dietary Supplement: rice bran |
| Control Group (Standard Care) | No intervention | Participants in this group will receive standard care during radiation therapy without rice bran supplementation. Their oral mucositis symptoms and quality of life will be monitored for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade ≥ 3 mucositis .
The proportion of patients who develop severe oral mucositis of grade 3 or higher, based on standardized clinical grading scales, during or after radiation therapy. Grade 3 mucositis is characterized by severe pain, ulceration, and an inability to eat solid foods without significant discomfort.
Measured: From the start of radiation therapy until 2 weeks after completion of treatment (approximately 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Jan 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-Induced Oral MucositisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group interventional study where participants are assigned to one of two groups. The active group receives rice bran supplements during radiation therapy, while the control group receives standard care without rice bran. The study compares the effects of rice bran on radiation-induced oral mucositis and quality of life between the two groups.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christina Milad Lobos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christina Milad Lobos, German University in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242859
- Sponsor's protocol ID
- RB-2025-01
- Acronym
- RICE-MUC
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rice Bran on Radiation-Induced Oral Mucositis in Patients With Head/Neck Cancer and Its Impact on the Quality of Life
- ClinicalTrials.gov ID
- NCT07242859
- Acronym / sponsor ID
- RICE-MUC / RB-2025-01
- Conditions
- Radiation-Induced Oral Mucositis, Head &Amp; Neck Cancer, Head &Amp; Neck Squamous Cell Carcinoma
- Keywords
- Radiation-Induced Oral Mucositis, Oral Mucositis, Head and Neck Cancer, Rice Bran, Dietary Supplement, Radiation Therapy Side Effects, Quality of Life, Supportive Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Christina Milad LobosUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Nov 2025 (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.
This study aims to find out if taking rice bran supplements can help reduce the painful mouth sores (oral mucositis) that often occur in patients with head and neck cancer who receive radiation therapy. The trial will include adult patients undergoing radiation treatment. Participants will be given rice bran supplements during their therapy to see if it can lessen these side effects and improve their overall quality of life.
Detailed description
Radiation-induced oral mucositis is a common and debilitating side effect experienced by patients undergoing radiation therapy for head and neck cancer. This condition causes painful inflammation and ulceration of the mucous membranes in the mouth, significantly impacting patients' ability to eat, speak, and maintain oral hygiene, thereby reducing their quality of life.
This study investigates the therapeutic potential of rice bran, a natural byproduct of rice milling rich in antioxidants and anti-inflammatory compounds, as a dietary supplement to mitigate the severity of oral mucositis. Participants will be adult patients diagnosed with head and neck cancer who are scheduled to receive radiation therapy.
The intervention involves administering rice bran supplements concurrently with radiation treatment. The study aims to evaluate the effects of rice bran on the incidence, duration, and severity of oral mucositis, as well as its overall impact on patients' quality of life during and after treatment.
By assessing clinical outcomes and patient-reported measures, this trial seeks to provide evidence on whether rice bran can serve as an effective, low-cost, and accessible supportive care option for managing radiation-induced oral mucositis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a parallel-group interventional study where participants are assigned to one of two groups. The active group receives rice bran supplements during radiation therapy, while the control group receives standard care without rice bran. The study compares the effects of rice bran on radiation-induced oral mucositis and quality of life between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Rice Bran Supplement Group | Experimental | Dietary Supplement: rice branParticipants in this group will receive rice bran supplements daily during their radiation therapy. The supplement is intended to reduce the severity of oral mucositis and improve quality of life. |
| Control Group (Standard Care) | No intervention | –Participants in this group will receive standard care during radiation therapy without rice bran supplementation. Their oral mucositis symptoms and quality of life will be monitored for comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients of age 18 years old tor more
- Patients with squamous cell carcinomas without metastases of other non-head and non-neck tumors.
- Patients undergoing radiotherapy with an ECOG performance status of 0, 1, or 2
- Patients who will receive IMRT delivered as radical or adjuvant therapy with or without concurrent chemotherapy
- Ready to provide written informed consent
Key exclusion criteria (4 listed)
- Receiving any other approved or investigational anti-cancer agent than those specified in this study.
- Pregnant or breastfeeding female patients
- Patients who have oral lesions unrelated to treatment or cancer,
- Patients who are on drugs that could cause oral lesions or are using anticoagulants.
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 |
|---|---|---|
| rice branAlso: OryzaParticipants in the intervention group will receive a standardized dose of rice bran supplement administered orally each day throughout the course of their radiation therapy. The rice bran used is a natural dietary supplement rich in antioxidants and anti-inflammatory compounds, aimed at reducing the severity and duration of radiation-induced oral mucositis in patients with head and neck cancer. | Dietary supplement | Rice Bran Supplement Group |
Primary outcome
Incidence of grade ≥ 3 mucositis .
Time frame: From the start of radiation therapy until 2 weeks after completion of treatment (approximately 8 weeks)
The proportion of patients who develop severe oral mucositis of grade 3 or higher, based on standardized clinical grading scales, during or after radiation therapy. Grade 3 mucositis is characterized by severe pain, ulceration, and an inability to eat solid foods without significant discomfort.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rice bran in people with Radiation-Induced Oral Mucositis and Head &Amp; Neck Cancer, run by Christina Milad Lobos 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Milad Lobos, Master (+20 1005279101, Krstina.Bqtr@pharm.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade ≥ 3 mucositis . (time frame: From the start of radiation therapy until 2 weeks after completion of treatment (approximately 8 weeks)). 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 21 Nov 2025.