Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Head and Neck Squamous Cell Carcinomas' Patients

Yao Liao

Status and phase: Unknown; Phase 4

Conditions: Early Radiation Dermatitis

Treatments: Drug: Mometasone Furoate Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02495064

MianyangCH

Details and patient eligibility

About

Radiation dermatitis is an acute effect of radiation therapy,Especially in the neck skin of head and neck squamous cell carcinomas' patients.The investigators wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study.

Full description

A randomized,self-comparative controlled trial was undertaken comparing MF cream with no cream administered from the first day of treatment for 5-6 weeks to prevent radiation dermatitis of neck during radiation therapy to the head and neck squamous cell carcinomas' Patients.

One side of patients' neck will begin to use MF cream from the first day of radiation therapy, while the other side accept no preventive measures.

Enrollment: 160 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pathological diagnosis for head and neck squamous cell carcinomas and
• going to have radiotherapy.

Exclusion criteria

• pregnant,
• lactating women,
• infants,
• elderly people with atrophy skin,
• allergic constitution patients,
• the corresponding parts of 5 radiotherapy skin ulceration or infection and
• allergic patients to Mometasone Furoate Cream.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Mometasone Furoate Cream(MF)

Experimental group

Description:

participants will be given conventional Chemoradiotherapy and MF. MF Brief introduction: Generic name :Mometasone Furoate Cream. Dosage form:Each gram of Mometasone Furoate Cream contains mometasone furoate, USP in a cream base of hexylene glycol, phosphoric acid, propylene glycol stearate, stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch octenylsuccinate, white wax, white petrolatum, and purified water. Dosage:Apply a thin film of Mometasone Furoate Cream to the affected skin areas once daily during radiotherapy. It is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Treatment:

Drug: Mometasone Furoate Cream

Chemoradiotherapy

No Intervention group

Description:

conventional Chemoradiotherapy only