Radiodermatitis
Conditions
Keywords
breast cancer, radiation, dermatitis
Brief summary
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.
Detailed description
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.
Interventions
DRUGDifinsa53
Difinsa53 cream is applied to one half of radiation field
DRUGAquaphor
Aquaphor is applied to one half of radiation field
Sponsors
Poudre Valley Health System
ProTechSure Scientific, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Female patients 18 years and older * Pathologic diagnosis of breast cancer requiring radiation therapy to whole breast * Able to apply lotion to treatment area at least twice daily during radiation course * All surgical sites healed * No evidence of infection * No history of sensitivity to any component in Aquaphor or Difensa53
Exclusion criteria
* Prior history of radiation therapy (RT) to that site * Known dermatologic conditions affecting skin in radiation port * Concurrent chemotherapy * Skin infection in radiation port * History of sensitivity to Aquaphor or Difensa53 component
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria | 8 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Difinsa53 and Aquaphor Arms |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Sex: Female, Male Participants Female | 13 Participants |
| Sex: Female, Male Participants Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
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.
Time frame: 8 weeks
Population: All patients were analyzed by blinded observor
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Difinsa 53 Arm | Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria | 0 units on a scale |
| Aquaphor Arm | Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria | 0 units on a scale |