Status:

COMPLETED

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

Lead Sponsor:

Trans Tasman Radiation Oncology Group

Collaborating Sponsors:

3M

Conditions:

Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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...

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 react...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2008

Estimated Enrollment :

333 Patients enrolled

Trial Details

Trial ID

NCT00193908

Start Date

March 1 2004

End Date

October 1 2008

Last Update

May 14 2009

Active Locations (12)

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Page 1 of 3 (12 locations)

1

St George Hospital

Kogarah, New South Wales, Australia, 2217

2

Liverpool Hospital

Liverpool, New South Wales, Australia, 1871

3

Calvary Mater Newcastle

Newcastle, New South Wales, Australia, 2298

4

Prince of Wales Hospital

Randwick, New South Wales, Australia, 2031