Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") Cream

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Cavilon (TM) Durable Barrier Cream; Drug: Sorbolene; Radiation: Radiotherapy	Phase 3

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	333 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Paired Double Blind Randomised Comparison of Cavilon(TM) Durable Barrier Cream(TM)[CDBC] to 10% Glycerine ("Sorbolene") Cream in the Prophylactic Management of Post-Mastectomy Irradiation Skin Care
Study Start Date :	March 2004
Actual Primary Completion Date :	September 2007
Actual Study Completion Date :	October 2008

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1	Drug: Cavilon (TM) Durable Barrier Cream; 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. Drug: Sorbolene; Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation Radiation: Radiotherapy; Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol; Other Name: Radiotherapy, Radiation Therapy
Experimental: 2	Drug: Cavilon (TM) Durable Barrier Cream; 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. Drug: Sorbolene; Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation Radiation: Radiotherapy; Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol; Other Name: Radiotherapy, Radiation Therapy

Outcome Measures

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Primary Outcome Measures :

1. Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks [ Time Frame: 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Ages 18 or more years
• Post total mastectomy
• Planned dose at least 45 Gy in 25 fractions
• ECOG 0-2
• Able to attend weekly during treatment for review and photo and for up to 6 weeks after radiotherapy
• Patients capable of childbearing using adequate contraception
• Written informed consent

Exclusion Criteria:

• Previous radiotherapy to the chest wall to be treated
• Macroscopic cutaneous involvement by malignancy at time of radiotherapy
• Known allergy to product contents
• Patients who are pregnant or lactating.

Contacts and Locations

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Locations

Australia, New South Wales
St George Hospital
Kogarah, New South Wales, Australia, 2217
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145
Wollongong Hospital
Wollongong, New South Wales, Australia
Australia, Queensland
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029
Mater QRI
South Brisbane, Queensland, Australia, 4101
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000

Sponsors and Collaborators

Trans-Tasman Radiation Oncology Group (TROG)

3M

Investigators

Study Chair:	Peter Graham	St George Hospital

More Information

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Additional Information:

Click here for more information about this study on the TROG official website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Dr Peter Graham, Trans Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:	NCT00193908 History of Changes
Other Study ID Numbers:	TROG 04.01
First Posted:	September 19, 2005
Last Update Posted:	May 14, 2009
Last Verified:	May 2009

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):

Skin care; Radiotherapy

Additional relevant MeSH terms:

Glycerol; Cryoprotective Agents; Protective Agents; Physiological Effects of Drugs