Clinical trial · Interventional
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
NCT00193908CI-TRIAL-00002302completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cavilon (TM) Durable Barrier Cream | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Sorbolene | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Cavilon (TM) Durable Barrier Cream
- Drug: Sorbolene
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: Cavilon (TM) Durable Barrier Cream
- Drug: Sorbolene
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area
- timeFrame
- 12 weeks
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGraham PH, Plant N, Graham JL, Browne L, Borg M, Capp A, Delaney GP, Harvey J, Kenny L, Francis M, Zissiadis Y. A paired, double-blind, randomized comparison of a moisturizing durable barrier cream to 10% glycerine cream in the prophylactic management of postmastectomy irradiation skin care: trans Tasman Radiation Oncology Group (TROG) 04.01. Int J Radiat Oncol Biol Phys. 2013 May 1;86(1):45-50. doi: 10.1016/j.ijrobp.2012.12.009. Epub 2013 Feb 12. PMID 23414763