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

Early Radiation Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02495064
• Other study ID #: MianyangCH
• Status: Recruiting
• Phase: Phase 4
• First received: January 25, 2015
• Last updated: March 8, 2016
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Mianyang Central Hospital
• Contact: Liao Yao
• Phone: 0086-13778106466
• Email: 425838503[@]qq.com
• Is FDA regulated: No
• Health authority: China: Sichuan Department of Science and Technology
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Dermatitis
• Early Radiation Dermatitis
• Eczema
• Head and Neck Neoplasms
• Radiodermatitis

Intervention

Drug:
• Mometasone Furoate Cream
One side of patients' neck will begain to use MF cream from the first day of radiation therapy.

Locations

Country	Name	City	State
China	oncology department of Mian yang central Hosptial	Mianyang	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Yao Liao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No