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
  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
Radiation: Radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Enrollment: 333
Study Start Date: March 2004
Study Completion Date: October 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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: 2 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145
Wollongong Hospital
Wollongong, New South Wales, Australia
Australia, Queensland
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029
Mater QRI
South Brisbane, Queensland, Australia, 4101
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
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 by Trans-Tasman Radiation Oncology Group (TROG)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Peter Graham, Trans Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00193908     History of Changes
Other Study ID Numbers: TROG 04.01
Study First Received: September 12, 2005
Last Updated: May 13, 2009
Health Authority: Australia: Human Research Ethics Committee

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014