Omega-3 Hydrogel and Prevention of Oral Mucositis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-09

Study Completion Date

2022-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Mucositis Oral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Topical oral Omega-3 hydrogel group

Patients will be given topical oral Omega-3 hydrogel

Group Type EXPERIMENTAL

topical oral Omega-3 hydrogel

Intervention Type DRUG

Topical oral Omega-3 hydrogel prepared from fish oil

Conventional preventive treatment group

Patients will be given conventional preventive treatment

Group Type ACTIVE_COMPARATOR

conventional preventive treatment

Intervention Type DRUG

topical treatment including antifungal agents, anti-inflammatory mouthwash, sodium bicarbonate mouthwash.

Topical anesthetics agent, topical analgesic gel as well as systemic analgesics (if needed)

Interventions

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topical oral Omega-3 hydrogel

Topical oral Omega-3 hydrogel prepared from fish oil

Intervention Type DRUG

conventional preventive treatment

topical treatment including antifungal agents, anti-inflammatory mouthwash, sodium bicarbonate mouthwash.

Topical anesthetics agent, topical analgesic gel as well as systemic analgesics (if needed)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No