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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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This study has patients using two different moisturising creams during radiation therapy after mastectomy. These are Cavilon and sorbolene. It is hypothesised that skin reactions may be reduced by the Cavilon cream compared to sorbolene.
Skin reactions are a common and undesirable result of radiation treatment. Preventative measures are often used although there are few controlled trials. Commonly employed agents for established reactions have included sorbolene (10% Glycerine), silver sulphadiazine, hydrocolloid dressings, topical steroids, salt water or bicarbonate of soda water solution bathing and hydrogen peroxide. One trial found that Cavilon No-Sting Barrier film reduced Grade 3 skin reaction compared to sorbolene, although this film did not contain any moisturising agents.
General Hypothesis: That in a paired double blind randomised study peak and overall skin reactions experienced by post mastectomy breast cancer patients receiving radiotherapy may be reduced by Cavilon Durable Barrier Cream (CDBC) compared to Sorbolene.
Alternative Hypothesis of primary outcome: the frequency of grade 3 or more skin reaction will be reduced from 35% to 25% for skin care using sorbolene or CDBC respectively.
Alternative Hypothesis of secondary outcome: the mean area under the curve (AUC) of total skin reaction will be reduced from 9 to 8 for skin care using sorbolene or CDBC respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cavilon (TM) Durable Barrier Cream | Drug | Cavilon (TM) Durable Barrier Cream will be applied to either the medial or the lateral side of the treated breast. Side will depend on randomisation. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Graham | St. George's Hospital, London | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St George Hospital | Kogarah | New South Wales | 2217 | Australia | ||
| Liverpool Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23414763 | Derived | Graham PH, Plant N, Graham JL, Browne L, Borg M, Capp A, Delaney GP, Harvey J, Kenny L, Francis M, Zissiadis Y. A paired, double-blind, randomized comparison of a moisturizing durable barrier cream to 10% glycerine cream in the prophylactic management of postmastectomy irradiation skin care: trans Tasman Radiation Oncology Group (TROG) 04.01. Int J Radiat Oncol Biol Phys. 2013 May 1;86(1):45-50. doi: 10.1016/j.ijrobp.2012.12.009. Epub 2013 Feb 12. |
| Label | URL |
|---|---|
| Click here for more information about this study on the TROG official website | View source |
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| Sorbolene | Drug | Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation |
|
| Radiotherapy | Radiation | Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol |
|
|
| Liverpool |
| New South Wales |
| 1871 |
| Australia |
| Calvary Mater Newcastle | Newcastle | New South Wales | 2298 | Australia |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Westmead Hospital | Wentworthville | New South Wales | 2145 | Australia |
| Wollongong Hospital | Wollongong | New South Wales | Australia |
| Royal Brisbane Hospital | Herston | Queensland | 4029 | Australia |
| Mater QRI | South Brisbane | Queensland | 4101 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Andrew Love Cancer Care Centre, Geelong Hospital | Geelong | Victoria | 3220 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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