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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Early Radiation Dermatitis

Intervention / Treatment
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* Drug: Mometasone Furoate Cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mometasone Furoate Cream(MF)<br>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. | Drug: Mometasone Furoate Cream<br>* One side of patients' neck will begain to use MF cream from the first day of radiation therapy.<br>* Other names: Eloson;|
| No Intervention: Chemoradiotherapy<br>conventional Chemoradiotherapy only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean Radiation Therapy Oncology Group (RTOG) skin dermatitis score | The investigators descriph the skin dermatitis scores every week during radiation therapy and the later two weeks as follows:The scores were 0 = no visible change; 1 = faint or dull erythema; 2 = tender or bright erythema with or without moist desquamation; 3 = patchy moist desquamation with moderate edema; and 4= confluent moist desquamation with pitting edema. | seven weeks |