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

Trans Tasman Radiation Oncology Group (TROG) 04.01 - 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 to reduce overall skin reactions.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000100493

Acronym

TROG 04.01

Enrollment

333

Registered

2004-07-28

Start date

2004-03-03

Completion date

2007-07-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Test Group 1: Apply Cavilon TM Durable Barrier Cream TM (CDBC - 1.3% dimethicone) to medial of the breast and sorbolene (10% Glycerine) to lateral side. Applied from day 1 post X-Ray Therapy (XRT) until 2 weeks XRT (approximately 7 weeks). All products applied topically. Test Group 2: Apply Cavilon TM Durable Barrier Cream TM (CDBC- 1.3% dimethicone) to lateral side of the breast and sorbolene (10% Glycerine) to the medial side. Applied from day 1 post X-Ray Therapy (XRT) until 2 weeks XRT (

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results