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Insufficient dermatitis was seen in the controls to allow any determination of protection by Difinsa53
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| Name | Class |
|---|---|
| Poudre Valley Health System | OTHER |
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Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.
The proposed study seeks to evaluate the efficacy of DIFINISA53™, a safe silibin-based skin cream, on preventing radiation dermatitis (RD) when compared to an over the counter ointment, Aquaphor, in women undergoing radiation therapy for breast cancer following lumpectomy or mastectomy surgery. Presently there is no known fully effective topical protectant from RD and there is no consensus among radiation oncologists on how best to treat RD. This study seeks to identify a more effective option for patients receiving radiation therapy. Each participant will apply the DIFINISA53™ cream to one area of the treated skin and Aquaphor to another area of treated skin. Skin reactions will be evaluated using medical professional assessment, participant assessment, and photographic assessment by a third party.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Difinsa53 | Drug | Difinsa53 cream is applied to one half of radiation field |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria | A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Petit, MD | UC Health, Poudre Valley Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poudre Valley Health System | Fort Collins | Colorado | 80528 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21514477 | Background | McQuestion M. Evidence-based skin care management in radiation therapy: clinical update. Semin Oncol Nurs. 2011 May;27(2):e1-17. doi: 10.1016/j.soncn.2011.02.009. | |
| 21786113 | Background | Becker-Schiebe M, Mengs U, Schaefer M, Bulitta M, Hoffmann W. Topical use of a silymarin-based preparation to prevent radiodermatitis : results of a prospective study in breast cancer patients. Strahlenther Onkol. 2011 Aug;187(8):485-91. doi: 10.1007/s00066-011-2204-z. Epub 2011 Jul 22. |
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13 patients were entered, each of whom had a single radiation port divided into two fields. One received aquaphor protection and the other received Difinsa53 protection.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aquaphor | This radiation field treated with aquaphor |
| FG001 | Difinsa53 | This radiation field treated with Difinsa53 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The analysis population consisted of 13 breast cancer patients receiving radiation to a breast. Each breast was divided into two radiation fields, one defined as the Difinsa53 arm and the other as the Aquaphor Arm. Thus each participant contributed data from two fields.
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| ID | Title | Description |
|---|---|---|
| BG000 | Difinsa53 and Aquaphor Arms | Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor Difinsa53: Difinsa53 cream is applied to one half of radiation field Aquaphor: Aquaphor is applied to one half of radiation field |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria | A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria. | All patients were analyzed by blinded observor | Posted | Median | Full Range | units on a scale | 8 weeks |
|
Data were collected over 12 weeks for each arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Difinsa53 Arm | Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor Difinsa53: Difinsa53 cream is applied to one half of radiation field |
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This trial was terminated early, based on minimal radiation dermatitis (scores of 0-1 only in most fields evaluated) that precluded any meaningful analysis of any differing effect in the two treatment arms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| L. Michael Glode, MD | ProTechSure Scientific Inc. | 303-526-9031 | mike.glode@ucdenver.edu |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| D001943 | Breast Neoplasms |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C501844 | dimethicone |
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Aquaphor | Drug | Aquaphor is applied to one half of radiation field |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor
Aquaphor: Aquaphor is applied to one half of radiation field
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Aquaphor Arm | Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor Aquaphor: Aquaphor is applied to one half of radiation field | 0 | 13 | 0 | 13 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |