Clinical trial · Interventional
Omega-3 Hydrogel and Prevention of Oral Mucositis
Efficacy of Topical Oral Omega-3 Hydrogel in Prevention of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Oral mucositis (OM) is recognized as one of the most frequent debilitating sequela encountered by head and neck cancer (HNC) patients treated by radiotherapy. The objective of the study is to assess primarily the effect of topical oral Omega-3 hydrogel in prevention of radiation-induced oral mucositis and secondarily, to test the effect of topical oral Omega-3 hydrogel on oral microbiome.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucositis Oral | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional preventive treatment | Drug | — | UNRESOLVED |
| topical oral Omega-3 hydrogel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Topical oral Omega-3 hydrogel group
- description
- Patients will be given topical oral Omega-3 hydrogel
- interventionNames
- Drug: topical oral Omega-3 hydrogel
- type
- ACTIVE_COMPARATOR
- label
- Conventional preventive treatment group
- description
- Patients will be given conventional preventive treatment
- interventionNames
- Drug: conventional preventive treatment
Primary outcomes (1)
- measure
- Oral Mucositis Severity
- timeFrame
- up to 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy. 2. Patients whose radiotherapy treatment planned dose is 50 Gy or above 3. Males and females with an age not less than 18 years 4. Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy. Exclusion Criteria: 1. Patients under Anticoagulants such as warfarin, heparin, or aspirin. 2. Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction) 3. Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
References
Publications (0)
Data not yet available