Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") Cream
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| ClinicalTrials.gov Identifier: NCT00193908 |
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Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : May 14, 2009
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Drug: Cavilon (TM) Durable Barrier Cream Drug: Sorbolene Radiation: Radiotherapy | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 333 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | March 2004 |
| Actual Primary Completion Date : | September 2007 |
| Actual Study Completion Date : | October 2008 |
| Arm | Intervention/treatment |
|---|---|
| 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 |
- Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area [ Time Frame: 12 weeks ]
- Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks [ Time Frame: 12 weeks ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193908
| 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 | |
| Study Chair: | Peter Graham | St George Hospital |
Additional Information:
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 |
| First Posted: | September 19, 2005 Key Record Dates |
| Last Update Posted: | May 14, 2009 |
| Last Verified: | May 2009 |
Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
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Skin care Radiotherapy |
Additional relevant MeSH terms:
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Glycerol Cryoprotective Agents Protective Agents Physiological Effects of Drugs |