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Trial registered on ANZCTR


Registration number
ACTRN12612000784819
Ethics application status
Approved
Date submitted
20/07/2012
Date registered
24/07/2012
Date last updated
30/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized trial of two creams in the skin care of patients receiving radiation therapy for breast cancer in the tropics
Scientific title
Is CavilonTM Durable Barrier Cream (treatment) more effective than 100% Pure Sorbolene Cream (control) at preventing moist desquamation in patients receiving radiation treatment to the breast in a tropical setting?
Secondary ID [1] 280884 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin reactions associated with radiation therapy for breast cancer 286954 0
Condition category
Condition code
Cancer 287292 287292 0 0
Breast
Skin 287318 287318 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: CavilonTM Durable Barrier Cream (active ingredient Dimethicone 1.3%), applied twice per day to radiation therapy treatment area. Applications to commence on first radiation therapy treatment day and continue for 4 weeks post completion of radiation therapy treatment (approximately 8-10 weeks).
Intervention code [1] 285316 0
Prevention
Intervention code [2] 285332 0
Treatment: Other
Comparator / control treatment
Control: 100% Pure Sorbolene Cream (Cetomacrogol cream aqueous APF) applied twice per day to radiation therapy treatment area. Applications to commence on first radiation therapy treatment day and continue for 4 weeks post completion of radiation therapy treatment (approximately 8-10 weeks).
Control group
Active

Outcomes
Primary outcome [1] 287567 0
Primary Outcome: moist desquamation as assessed by nurses during treatment, and as graded by nurses from participants' description one month following treatment completion, using the CTCAEv4
Timepoint [1] 287567 0
Timepoint: Weekly during treatment, and 4 weeks after radiation therapy treatment completion
Secondary outcome [1] 298418 0
Secondary Outcome: Patient acceptability of the allocated cream based on a survey completed by participants
Timepoint [1] 298418 0
Timepoint: weekly during treatment, and one month following completion of treatment

Eligibility
Key inclusion criteria
Patients undergoing radiation treatment at the Radiation Oncology Unit, The Townsville Hospital, for cancer of the breast, and who:
1. Are 18 years or older, and
2. Are able to read, write, and speak English and able to comprehend and follow the study instructions, and
3. Are willing to consent to their inclusion in the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing radiation treatment at the Radiation Oncology Unit, The Townsville Hospital, for cancer of the breast, and who:
1. Are undergoing radiation therapy for palliative reasons, and/or
2. Have specific breast lesions that receive treatment that differs significantly in terms of dosage and duration to the routine regimen, and/or
3. Have a known allergy to either Sorbolene or Cavilon cream, and/or
4. Are unable to provide their written consent owing to an intellectual or mental impairment, and/or
5. Are deemed by the Radiation Oncologist to be not suitable to be invited to participate in the study, and/or
6. Decline to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After obtaining consents, participants stratified according to chest wall or breast treatment area, and allocated cream. Neither participants or staff involved in recruitment were aware of which cream would be allocated. Recruiter to contact holder of allocation schedule from the Research Unit, separate to the study site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization process will be managed by researchers from the Tropical Health Research Unit. Random allocation of participants will be achieved using a web-based computer generated program (www.randomization.com). There are two groups (Sorbolene and Cavilon); and two strata of participants (breast and chest wall) related to the skin areas irradiated.
Although blinding of nurses and participants to the cream being used by individuals is not possible because of their different textures and other properties, all participants and staff involved in recruiting participants, treating participants or collecting data will be excluded from the randomization process
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 285673 0
Hospital
Name [1] 285673 0
Townsville Hospital Private Practice Research and Education Trust Fund
Address [1] 285673 0
The Townsville Hospital
PO Box 670
Townsville, Qld, 4810
Country [1] 285673 0
Australia
Funding source category [2] 285674 0
Government body
Name [2] 285674 0
Queensland Health Nursing and Midwifery Grant
Address [2] 285674 0
Office of the Chief Nursing Officer
GPO Box 48
Brisbane, Qld, 4001
Country [2] 285674 0
Australia
Primary sponsor type
Hospital
Name
Townsville Health Service District
Address
The Townsville Hospital
PO Box 670
Townsville, Qld, 4810
Country
Australia
Secondary sponsor category [1] 284503 0
None
Name [1] 284503 0
Address [1] 284503 0
Country [1] 284503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287661 0
Townsville Health Service District Human Research Ethics Committee
Ethics committee address [1] 287661 0
The Townsville Hospital
PO Box 670
Townsville, Qld, 4810
Ethics committee country [1] 287661 0
Australia
Date submitted for ethics approval [1] 287661 0
Approval date [1] 287661 0
07/12/2009
Ethics approval number [1] 287661 0
HREC/09/QTHS/102

Summary
Brief summary
The purpose of this study is to compare two proven skin care products (creams) in the context of patients undergoing radiation therapy for breast cancer in the tropics.

Who is it for?
you may be eligible to join this study if you are aged 18 years or older and are undergoing radiation treatment at the Radiation Oncology Unit, The Townsville Hospital, for cancer of the breast.

Trial details
Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will apply CavilonTM Durable Barrier Cream twice per day to the radiation therapy treatment area from the first day of treatment up until 4 weeks following the end of the radiation therapy. Participants in the other group will use 100% Pure Sorbolene cream instead.

Participants will be assessed weekly during treatment and at one month post treatment in order to identify if one cream is more effective than the other at preventing skin reactions associated with radiation therapy for breast cancer.
Trial website
Trial related presentations / publications
Fasugba, O., Gardner, A., & Smyth, W. (2014). The Fitzpatrick skin type scale: A reliability and validity study in women undergoing radiation therapy for breast cancer. Journal of Wound Care, 23(7), 358-368.
Heyer, E., Smyth, W., Laffin, N., & Gardner, A. (2015). Protocol paper: A randomized trial of 2 creams in the skin care of patients receiving radiation therapy for breast cancer in the tropics. Cancer Nursing: An International Journal for Cancer Care, 38(4), E35-E41. doi:10.1097/NCC.0000000000000175
Laffin, N., Smyth, W., Heyer, E., Fasugba, O., Abernethy, G., & Gardner, A. (2015). Effectiveness and acceptability of a moisturizing cream and a barrier cream during radiation therapy for breast cancer in the tropics: A randomized controlled trial. Cancer Nursing: An International Journal for Cancer Care, 38(3), 205-214. doi:10.1097/NCC.0000000000000161
Public notes

Contacts
Principal investigator
Name 34464 0
Dr Wendy Smyth
Address 34464 0
Nursing and midwifery research
Townsville Hospital
100 Angus Smith Drive
Douglas
Qld, 4814
Country 34464 0
Australia
Phone 34464 0
+610744332666
Fax 34464 0
Email 34464 0
wendy.smyth@health.qld.gov.au
Contact person for public queries
Name 17711 0
Dr Dr Wendy Smyth
Address 17711 0
Tropical Health Research Unit for Nursing and Midwifery Practice
Internal mail box 105
The Townsville Hospital
100 Angus Smith Drive
Douglas, Qld, 4814
Country 17711 0
Australia
Phone 17711 0
+61 7 44332666
Fax 17711 0
Email 17711 0
Wendy_Smyth@health.qld.gov.au
Contact person for scientific queries
Name 8639 0
Dr Dr Wendy Smyth
Address 8639 0
Tropical Health Research Unit for Nursing and Midwifery Practice
Internal mail box 105
The Townsville Hospital
100 Angus Smith Drive
Douglas, Qld, 4814
Country 8639 0
Australia
Phone 8639 0
+61 7 44332666
Fax 8639 0
Email 8639 0
Wendy_Smyth@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary