Omega-3 Hydrogel and Prevention of Oral Mucositis

Basma Morsy

Status and phase: Completed; Phase 3; Phase 2

Conditions: Mucositis Oral

Treatments: Drug: conventional preventive treatment; Drug: topical oral Omega-3 hydrogel

Study type: Interventional

Funder types: Other

Identifiers

NCT05214495

0290-09/2021

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Topical oral Omega-3 hydrogel group

Experimental group

Description:

Patients will be given topical oral Omega-3 hydrogel

Treatment:

Drug: topical oral Omega-3 hydrogel

Conventional preventive treatment group

Active Comparator group

Description:

Patients will be given conventional preventive treatment

Treatment:

Drug: conventional preventive treatment