Breast CancerPhase 3NCT00193908
Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") Cream
A Phase 3 study testing Cavilon (TM) Durable Barrier Cream, Sorbolene and Radiotherapy in people with Breast Cancer, run by Trans Tasman Radiation Oncology Group at 12 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cavilon (TM) Durable Barrier Cream, Sorbolene and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 12 sitesAustralia
- Study dates
- Mar 2004to Oct 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Australia12 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, 3220
Royal Brisbane Hospital
Herston, Queensland, 4029
St George Hospital
Kogarah, New South Wales, 2217
Liverpool Hospital
Liverpool, New South Wales, 1871
Calvary Mater Newcastle
Newcastle, New South Wales, 2298
Royal Perth Hospital
Perth, Western Australia, 6000
Prince of Wales Hospital
Randwick, New South Wales, 2031
Mater QRI
South Brisbane, Queensland, 4101
Westmead Hospital
Wentworthville, New South Wales, 2145
Wollongong Hospital
Wollongong, New South Wales
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this 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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Cavilon (TM) Durable Barrier Cream, Sorbolene, Radiotherapy
- Keywords
- Skin care, Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cavilon (TM) Durable Barrier CreamDrug
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.
SorboleneDrug
Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation
RadiotherapyRadiation
Also called Radiotherapy, Radiation Therapy
Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Cavilon (TM) Durable Barrier Cream; Drug: Sorbolene; Radiation: Radiotherapy |
| 2 | Experimental | Not described Receives: Drug: Cavilon (TM) Durable Barrier Cream; Drug: Sorbolene; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area
Measured: 12 weeks
Secondary outcomes (1)
Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionSep 2007
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Investigators
- Peter Graham, Study chair, St. George's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193908
- Sponsor's protocol ID
- TROG 04.01
- Status last verified
- May 2009
- First submitted
- 12 Sep 2005
- Last updated
- 14 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23414763
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00193908
- Acronym / sponsor ID
- TROG 04.01
- Conditions
- Breast Cancer
- Keywords
- Skin care, Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Collaborators
- 3M
- Study start
- Mar 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cavilon (TM) Durable Barrier Cream, Drug: Sorbolene, Radiation: Radiotherapy |
| 2 | Experimental | Drug: Cavilon (TM) Durable Barrier Cream, Drug: Sorbolene, Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cavilon (TM) Durable Barrier CreamCavilon (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 | 1, 2 |
| SorboleneSorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation | Drug | 1, 2 |
| RadiotherapyAlso: Radiotherapy, Radiation TherapyMinimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol | Radiation | 1, 2 |
Primary outcome
Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area
Time frame: 12 weeks
1 secondary outcome
Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2009.
- Derived from this study: PubMed 23414763Graham 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.
- Click here for more information about this study on the TROG official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Graham study chair
St. George's Hospital, London
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cavilon (TM) Durable Barrier Cream, Sorbolene and Radiotherapy in people with Breast Cancer, run by Trans Tasman Radiation Oncology Group at 12 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00193908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2009.