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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193908
• Other study ID #: TROG 04.01
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 13, 2009
• Start date: March 2004
• Est. completion date: October 2008

Study information

• Verified date: May 2009
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: October 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.
• 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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Andrew Love Cancer Care Centre, Geelong Hospital	Geelong	Victoria
Australia	Royal Brisbane Hospital	Herston	Queensland
Australia	St George Hospital	Kogarah	New South Wales
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Calvary Mater Newcastle	Newcastle	New South Wales
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Mater QRI	South Brisbane	Queensland
Australia	Westmead Hospital	Wentworthville	New South Wales
Australia	Wollongong Hospital	Wollongong	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Trans-Tasman Radiation Oncology Group (TROG)	3M

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area		12 weeks	Yes
Secondary	Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks		12 weeks	Yes

External Links

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