NCT02495064

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

January 25, 2015

Last Update Submit

March 8, 2016

Conditions

Early Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Mometasone Furoate Cream(MF)

EXPERIMENTAL

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

Chemoradiotherapy

NO INTERVENTION

conventional Chemoradiotherapy only

Interventions

Mometasone Furoate CreamDRUG

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

Also known as: Eloson
Mometasone Furoate Cream(MF)

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

oncology department of Mian yang central Hosptial

Mianyang, Sichuan, 0816, China

RECRUITING

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesRadiation InjuriesWounds and Injuries

Study Officials

  • Wang dong

    Health Bureau of Mian Yang

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liao Yao

CONTACT

0086-13778106466425838503@qq.com

Du X Bo

CONTACT

0086-13550822229duxiaobo2005@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor of oncology department in Mianyang Central Hospital

Study Record Dates

First Submitted

January 25, 2015

First Posted

July 13, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations

CN(1)