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Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") Cream
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Trans-Tasman Radiation Oncology Group (TROG)
3M
Information provided by: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00193908
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Cavilon (TM) Durable Barrier Cream
Drug: Sorbolene
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Mastectomy Radiation Therapy
Drug Information available for: Sorbolene
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: 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

Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks [ Time Frame: 12 weeks ]

Estimated Enrollment: 330
Study Start Date: March 2004
Estimated Study Completion Date: October 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193908

Locations
Australia, New South Wales
St George Hospital
Kogarah, New South Wales, Australia, 2217
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, Australia, 2298
Wollongong Hospital
Wollongong, New South Wales, Australia
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Mater QRI
South Brisbane, Queensland, Australia, 4101
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
3M
Investigators
Study Chair: Peter Graham St George Hospital
  More Information

Additional Information:
No publications provided

Study ID Numbers: TROG 04.01
Study First Received: September 12, 2005
Last Updated: July 31, 2007
ClinicalTrials.gov Identifier: NCT00193908  
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Skin care
Radiotherapy

Study placed in the following topic categories:
Glycerol
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on February 12, 2009