Efficacy of EGF-loaded Self Healing Gel in Treatment 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Cancer treatment, including radiation along with aggressive chemotherapy, increases the patient's survival rate. However, they possess toxic side effects. Oral mucositis is one of the most serious complications of cancer treatment, which occurs in most of patients receiving cancer therapy. Mucositis can dramatically affect the patient's quality of life .Epidermal growth factor (EGF) is a dominant factor in early keratinocyte differentiation, proliferation and migration. However, a major obstacle in most studies is that there isn't prolonged contact between the applied treatment and the oral mucosa to achieve the optimum therapeutic effect. Thus, a new vehicle for EGF is needed to achieve sufficient prolonged contact with oral mucosa. The present project aims at employing EGF as therapeutic agent for mucositis dealing with the challenges of delivery of such macromolecule to the oral mucosa by using self-healing gels to maximize the drug effect.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Omega-3 Hydrogel and Prevention of Oral Mucositis

NCT05214495

Mucositis Oral

COMPLETED PHASE2/PHASE3

Effect of Aloe Vera Gel and Manuka Honey on Radiation Induced Oral Mucositis

NCT06381635

Radiation Mucositis

RECRUITING NA

The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients

NCT01099891

Stomatitis

UNKNOWN PHASE3

Efficacy of Glutamine in Management of Radiation Mucositis

NCT05856188

Radiation-Induced Mucositis

UNKNOWN NA

Curcumin Gel On Radiation Induced Oral Mucositis

NCT05982197

Radiation-Induced Mucositis Head and Neck Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Mucositis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Containers supplied for groups I and II will be identical and will be supplied by a third party pharmacist not a member of this study to ensure participant and patient blinding.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EGF loaded Hydrogel (Gp I)

30 patients will receive EGF loaded Hydrogel (Intervention 1) to be applied three times a day for 1weeks.

Group Type EXPERIMENTAL

EGF loaded Hydrogel

Intervention Type DRUG

Patients will receive 25 Ug/day of EGF. This is the estimated daily dose that will be obtained when the patient applies the gel thrice daily. Patients will receive the treatment for one week

Hydrogel alone ( Gp II)

30 patients will receive Hydrogel alone (Intervention 2) to be applied three times a day for 2 weeks.

Group Type ACTIVE_COMPARATOR

Hydrogel

Intervention Type DRUG

Non-medicated self-healing hydrogel to be applied three times a day for 1 week

Control (Gp III)

30 patients will receive the standard of care treatment (Control) which includes benzydamine mouthwash, increased hydration, topical analgesics and antifungals.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EGF loaded Hydrogel

Patients will receive 25 Ug/day of EGF. This is the estimated daily dose that will be obtained when the patient applies the gel thrice daily. Patients will receive the treatment for one week

Intervention Type DRUG

Hydrogel

Non-medicated self-healing hydrogel to be applied three times a day for 1 week

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Epidermal Growth Factor-loaded Hydrogel Self-healing Hydrogel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Eligible patients are those over 18 years of age with WHO grade 3 or 4 oral mucositis receiving radio- or chemotherapy as treatment for head and neck cancer.