Radiation-Induced MucositisNCT05982197
Curcumin Gel On Radiation Induced Oral Mucositis
A study testing Curcumin Gel and Standard Preparation in people with Radiation-Induced Mucositis and Head and Neck Cancer, run by University of Baghdad at 1 site in Iraq.
Trial summary
The goal of this clinical study is to investigate the effect of a curcuma longa oral gel (curenext) on reducing radiation-induced oral mucositis severity in cancer patients and provide a context for understanding if there is a relationship between the curcumin clinical effect and production of EGFs and IL8. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Radiation-Induced Mucositis, Head and Neck Cancer
- What is being tested?
- Curcumin Gel and Standard Preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 3 Jan 2023to 2 Jul 2023
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients above 16 years having histopathologically confirmed cancer in head and neck region who planned to have radiation with head and neck mask.
- Scheduled for 6-8 weeks of radiotherapy with 60-70Gy radiation (200cgy/fraction for 5 days/week).
Who cannot join
- patient with hodgkin lymphoma.
- Any allergy to curcumin or other condiments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Curcuma Long Oral Gel in Relation to Salivary Epidermal Growth Factor & Interleukin-8 on Radiation Induced Oral Mucositis in Iraqi Cancer Patients
The goal of this clinical study is to investigate the effect of a curcuma longa oral gel (curenext) on reducing radiation-induced oral mucositis severity in cancer patients and provide a context for understanding if there is a relationship between the curcumin clinical effect and production of EGFs and IL8.
Researchers will compare between curcumin group and standard treatment group.
- Conditions
- Radiation-Induced Mucositis, Head and Neck Cancer
- Being tested
- Curcumin Gel, Standard Preparation
- Keywords
- Radiation induced oral mucositis, Head and neck cancer, Curcuma longa, EGF, IL8
- 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.
Curcumin GelDrug
Curcuma longa oral gel for prevention radiation induced oral mucositis
Standard PreparationDrug
Standard preparation for prevention radiation induced oral mucositis
| Study group | Role | What they receive |
|---|---|---|
| Curcuma longa oral gel group | Active comparator | Not described Receives: Drug: Curcumin Gel |
| Standard treatment group | Active comparator | Not described Receives: Drug: Standard Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of radiation induced mucositis
Onset (at which week) of radiation induced mucositis in relation to EGF and IL8
Measured: Assessment every week starting from first visit until the onset of mucositis (up to 2 months)
Change in severity of radiation induced mucositis
Change in severity (degree of illness) of radiation induced mucositis in relation to EGF \& IL-8 by World Health Organization (WHO) mucositis scale {0: no. 1: mild. 2 and 3 : moderate. 4: severe}
Measured: Assessment every week starting from first visit of radiation unit it completion (average of 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start3 Jan 2023
- Primary completion1 Mar 2023
- Study completion2 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-Induced MucositisStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups A) curcuma longa oral gel group B) standard treatment group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah adnan abdul-jabbar, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982197
- Sponsor's protocol ID
- 705722
- Status last verified
- Aug 2023
- First submitted
- 22 Jun 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Curcuma Long Oral Gel in Relation to Salivary Epidermal Growth Factor & Interleukin-8 on Radiation Induced Oral Mucositis in Iraqi Cancer Patients
- ClinicalTrials.gov ID
- NCT05982197
- Acronym / sponsor ID
- 705722
- Conditions
- Radiation-Induced Mucositis, Head and Neck Cancer
- Keywords
- Radiation induced oral mucositis, Head and neck cancer, Curcuma longa, EGF, IL8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 2 Jul 2023 (actual)
- First posted
- 8 Aug 2023 (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.
The goal of this clinical study is to investigate the effect of a curcuma longa oral gel (curenext) on reducing radiation-induced oral mucositis severity in cancer patients and provide a context for understanding if there is a relationship between the curcumin clinical effect and production of EGFs and IL8.
Researchers will compare between curcumin group and standard treatment group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups A) curcuma longa oral gel group B) standard treatment group
| Arm | Type | Receives |
|---|---|---|
| Curcuma longa oral gel group | Active comparator | Drug: Curcumin Gel |
| Standard treatment group | Active comparator | Drug: Standard Preparation |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients above 16 years having histopathologically confirmed cancer in head and neck region who planned to have radiation with head and neck mask.
- Scheduled for 6-8 weeks of radiotherapy with 60-70Gy radiation (200cgy/fraction for 5 days/week).
Key exclusion criteria (2 listed)
- patient with hodgkin lymphoma.
- Any allergy to curcumin or other condiments.
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 |
|---|---|---|
| Curcumin GelCurcuma longa oral gel for prevention radiation induced oral mucositis | Drug | Curcuma longa oral gel group |
| Standard PreparationStandard preparation for prevention radiation induced oral mucositis | Drug | Standard treatment group |
Primary outcome
Onset of radiation induced mucositis
Time frame: Assessment every week starting from first visit until the onset of mucositis (up to 2 months)
Onset (at which week) of radiation induced mucositis in relation to EGF and IL8
Change in severity of radiation induced mucositis
Time frame: Assessment every week starting from first visit of radiation unit it completion (average of 2 months)
Change in severity (degree of illness) of radiation induced mucositis in relation to EGF \& IL-8 by World Health Organization (WHO) mucositis scale {0: no. 1: mild. 2 and 3 : moderate. 4: severe}
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 8 Aug 2023.
Related trials for Radiation-Induced Mucositis
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin Gel and Standard Preparation in people with Radiation-Induced Mucositis and Head and Neck Cancer, run by University of Baghdad at 1 site in Iraq.
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 2 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 8 Aug 2023. 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 Iraq. 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?
Onset of radiation induced mucositis (time frame: Assessment every week starting from first visit until the onset of mucositis (up to 2 months)). The study lists 2 primary outcomes in all. 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 8 Aug 2023.