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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193908

Enrollment

333

Registered

2005-09-19

Start date

2004-03-31

Completion date

2008-10-31

Last updated

2009-05-14

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

Conditions

Breast Cancer

Keywords

Skin care, Radiotherapy

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.

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.

Interventions

DRUGCavilon (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.

DRUGSorbolene

Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation

RADIATIONRadiotherapy

Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026