Condition category
Signs and Symptoms
Date applied
07/07/2010
Date assigned
07/07/2010
Last edited
16/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Helen Spickett

ORCID ID

Contact details

Rosemere Cancer Centre
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
helen.spickett@lsccn.nhs.uk

Additional identifiers

EudraCT number

2006-002352-15

ClinicalTrials.gov number

Protocol/serial number

2191

Study information

Scientific title

Acronym

Skin Study

Study hypothesis

A prospective, double blind, randomised study investigating the effect of mometasone furoate on the prevention of radiation dermatitis of the breast and chest wall. Scoring systems include visual scoring and reflectance spectrometry. Participants receiving a 40 Gy, 15 fractionated, 3 week radical course of whole breast radiotherapy plus or minus breast boost will be eligible.

As of 17/02/2011 the anticipated end date for this trial has been updated from 01/01/2010 to 31/07/2011.

Ethics approval

MREC approved (ref: 06/Q0201/79)

Study design

Single centre randomised interventional process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast

Intervention

Placebo or mometasone furoate. Assessments are taken at baseline, day 8, 15, 21, 29, 36 and 43.

Study entry: single randomisation only

Intervention type

Drug

Phase

Phase III

Drug names

Mometasone furoate

Primary outcome measures

Change in visual skin assessment

Secondary outcome measures

1. Objective skin assessment
2. Changes in quality of life measures

Overall trial start date

02/11/2009

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over, either sex
2. Receiving 40 Gy 15 fractionated, 3 week radical radiotherapy to the breast or chest wall
3. Patient provides informed consent to participate in the study and completes follow up

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 120; UK sample size: 120

Participant exclusion criteria

1. Skin involvement of disease
2. Untreated bacterial, fungal or viral skin lesions
3. Inability to self administer creams

Recruitment start date

02/11/2009

Recruitment end date

31/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rosemere Cancer Centre
Preston
PR2 9HT
United Kingdom

Sponsor information

Organisation

Lancashire Teaching Hospitals NHS Trust (UK)

Sponsor details

Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.lancsteachinghospitals.nhs.uk/

Funders

Funder type

Charity

Funder name

Rosemere Cancer Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes