A randomised, double-blind controlled trial of mometosone furoate cream versus placebo to prevent radiation dermatitis of the breast and chest wall
| ISRCTN | ISRCTN03885092 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03885092 |
| EudraCT/CTIS number | 2006-002352-15 |
| Secondary identifying numbers | 2191 |
- Submission date
- 07/07/2010
- Registration date
- 07/07/2010
- Last edited
- 24/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Helen Spickett
Scientific
Scientific
Rosemere Cancer Centre
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
| helen.spickett@lsccn.nhs.uk |
Study information
| Study design | Single centre randomised interventional process of care trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | A randomised, double-blind controlled trial of mometosone furoate cream versus placebo to prevent radiation dermatitis of the breast and chest wall |
| Study acronym | Skin Study |
| Study objectives | 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. |
| Ethics approval(s) | MREC approved (ref: 06/Q0201/79) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Mometasone furoate |
| Primary outcome measure | Change in visual skin assessment |
| Secondary outcome measures | 1. Objective skin assessment 2. Changes in quality of life measures |
| Overall study start date | 02/11/2009 |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 120; UK sample size: 120 |
| Key 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 |
| Key exclusion criteria | 1. Skin involvement of disease 2. Untreated bacterial, fungal or viral skin lesions 3. Inability to self administer creams |
| Date of first enrolment | 02/11/2009 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Rosemere Cancer Centre
Preston
PR2 9HT
United Kingdom
PR2 9HT
United Kingdom
Sponsor information
Lancashire Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
England
United Kingdom
| Website | http://www.lancsteachinghospitals.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/02j7n9748 |
Funders
Funder type
Charity
Rosemere Cancer Foundation (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | 24/01/2022 | No | Yes | ||
| Results article | 15/11/2014 | 24/01/2022 | Yes | No |
Editorial Notes
24/01/2022: The following changes were made to the trial record:
1. A link to plain English results was added.
2. Publication reference added.
14/03/2017: No publications found in PubMed, verifying study status with principal investigator
17/02/2011: The anticipated end date for this trial has been updated from 01/01/2010 to 31/07/2011.
