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

Phase 3

Completed

• Conditions: Post-mastectomy; Other - Breast; Other - Dermatological conditions

• Registration Number: ACTRN12607000100493
• Lead Sponsor: Peter Graham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-07-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Age 18 or more years. No upper limit.2. Post total mastectomy. Timing is not of relevance to this study therefore no limit.3. Planned dose at least 45 Gy in 25 fractions.4. Eastern Co-operative Oncology Group (ECOG) 0-2.5. Able to attend weekly during treatment for review and photo and up to 6 weeks after radiotherpay if reaction does not resolve prior.6. Patients capable of childbearing using adequate contraception.7. written informed consent.

Exclusion Criteria

Exclusion:1. previous radiotherapy to the chest wall to be treated, either as definitive treatment or as entry/exit dose from previuos intra-thoracic malignancy radiotherapy.2. Macroscopic cutaneous involvement by malignancy at time of radiotherapy.3. patients who are pregnant or lactating4. known allergy to product contents

Study & Design

• Study Type: Interventional
• Study Design: Not specified