Back to resultsMometasone Furoate Cream Reduces Acute Radiation Dermatitis in Head and Neck Squamous Cell Carcinomas' Patients
Primary Purpose
Early Radiation Dermatitis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Mometasone Furoate Cream
Sponsored by
About this trial
This is an interventional health services research trial for Early Radiation Dermatitis
Eligibility Criteria
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.
Sites / Locations
- oncology department of Mian yang central HosptialRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mometasone Furoate Cream(MF)
Chemoradiotherapy
Arm 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.
conventional Chemoradiotherapy only
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02495064
Brief Title
Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Head and Neck Squamous Cell Carcinomas' Patients
Official Title
Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Head and Neck Squamous Cell Carcinomas' Patients Receiving Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yao Liao
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Radiation Dermatitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mometasone Furoate Cream(MF)
Arm Type
Experimental
Arm 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.
Arm Title
Chemoradiotherapy
Arm Type
No Intervention
Arm Description
conventional Chemoradiotherapy only
Intervention Type
Drug
Intervention Name(s)
Mometasone Furoate Cream
Other Intervention Name(s)
Eloson
Intervention Description
One side of patients' neck will begain to use MF cream from the first day of radiation therapy.
Primary Outcome Measure Information:
Title
the mean Radiation Therapy Oncology Group (RTOG) skin dermatitis score
Description
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.
Time Frame
seven weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liao Yao
Phone
0086-13778106466
Email
425838503@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Du X Bo
Phone
0086-13550822229
Email
duxiaobo2005@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang dong
Organizational Affiliation
Health Bureau of Mian Yang
Official's Role
Principal Investigator
Facility Information:
Facility Name
oncology department of Mian yang central Hosptial
City
Mianyang
State/Province
Sichuan
ZIP/Postal Code
0816
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liao Yao, Resident
Phone
0086-13778106466
Email
425838503@qq.com
First Name & Middle Initial & Last Name & Degree
Du x bo, Chief
Phone
0086-13550822229
Email
duxiaobo2005@126.com
12. IPD Sharing Statement
Learn more about this trial
Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Head and Neck Squamous Cell Carcinomas' Patients
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