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

May 13, 2009 updated by: Trans Tasman Radiation Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

333

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Radiotherapy, Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trans Tasman Radiation Oncology Group

Collaborators

3M

Investigators

  • Study Chair: Peter Graham, St George Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

May 14, 2009

Last Update Submitted That Met QC Criteria

May 13, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TROG 04.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe