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

NCT ID: NCT02495064

Last Updated: 2016-03-09

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-12-31

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.

Conditions

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Early Radiation Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Mometasone Furoate Cream(MF)

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.

Group Type EXPERIMENTAL

Mometasone Furoate Cream

Intervention Type DRUG

One side of patients' neck will begain to use MF cream from the first day of radiation therapy.

Chemoradiotherapy

conventional Chemoradiotherapy only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mometasone Furoate Cream

One side of patients' neck will begain to use MF cream from the first day of radiation therapy.

Intervention Type DRUG

Other Intervention Names

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Eloson

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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yao Liao

OTHER

Sponsor Role lead

Responsible Party

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Yao Liao

Doctor of oncology department in Mianyang Central Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wang dong

Role: PRINCIPAL_INVESTIGATOR

Health Bureau of Mian Yang

Locations

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oncology department of Mian yang central Hosptial

Mianyang, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liao Yao

Role: CONTACT

0086-13778106466

Du X Bo

Role: CONTACT

0086-13550822229

Facility Contacts

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Liao Yao, Resident

Role: primary

0086-13778106466

Du x bo, Chief

Role: backup

0086-13550822229

Other Identifiers

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MianyangCH

Identifier Type: -

Identifier Source: org_study_id

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