Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
3M
Information provided by:
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00193908
First received: September 12, 2005
Last updated: May 13, 2009
Last verified: May 2009

September 12, 2005
May 13, 2009
March 2004
September 2007   (final data collection date for primary outcome measure)
Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Frequency of moist desquamation (grade3) acute skin reaction scored as worst reaction within allocated skin care area.
Complete list of historical versions of study NCT00193908 on ClinicalTrials.gov Archive Site
Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks.
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Cavilon (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.
  • Drug: Sorbolene
    Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation
  • Radiation: Radiotherapy
    Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol
    Other Name: Radiotherapy, Radiation Therapy
  • Experimental: 1
    Interventions:
    • Drug: Cavilon (TM) Durable Barrier Cream
    • Drug: Sorbolene
    • Radiation: Radiotherapy
  • Experimental: 2
    Interventions:
    • Drug: Cavilon (TM) Durable Barrier Cream
    • Drug: Sorbolene
    • Radiation: Radiotherapy
Graham 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
333
October 2008
September 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00193908
TROG 04.01
No
Dr Peter Graham, Trans Tasman Radiation Oncology Group (TROG)
Trans-Tasman Radiation Oncology Group (TROG)
3M
Study Chair: Peter Graham St George Hospital
Trans-Tasman Radiation Oncology Group (TROG)
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP