Trial Outcomes & Findings for HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer (NCT NCT02165605)
NCT ID: NCT02165605
Last Updated: 2020-10-22
Results Overview
NCI-CTC (National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Week 5 during radiation therapy
Results posted on
2020-10-22
Participant Flow
Participant milestones
| Measure |
HA Serum Vs. Control Cream (Placebo)
Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the other breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within 4 hours prior to radiation treatment.
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|---|---|
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Overall Study
STARTED
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28
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Overall Study
COMPLETED
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28
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer
Baseline characteristics by cohort
| Measure |
Hylacare-Experimental
n=28 Participants
HylaCare cream-Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily, but not within 4 hours prior to radiation treatment. The patient is her own control.
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|---|---|
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Age, Continuous
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60 years
n=5 Participants
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Sex: Female, Male
Female
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28 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Week 5 during radiation therapyPopulation: All 28 patients were assigned to both arms HA formulation (Hylacare study cream) on the medial or lateral half of the irradiated breast and the control cream (placebo) on the other half. Each patient will use both HA study cream and placebo cream on breast receiving radiation treatment.
NCI-CTC (National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.
Outcome measures
| Measure |
HylaCare
n=28 Participants
Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.
|
Placebo
n=28 Participants
Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.
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|---|---|---|
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Acute Skin Toxicity Per NCI-CTC v4.0
Grade 0
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3 Participants
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3 Participants
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Acute Skin Toxicity Per NCI-CTC v4.0
Grade 1
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19 Participants
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18 Participants
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Acute Skin Toxicity Per NCI-CTC v4.0
Grade 2
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6 Participants
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7 Participants
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Acute Skin Toxicity Per NCI-CTC v4.0
Grade ≥3
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0 Participants
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0 Participants
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PRIMARY outcome
Timeframe: Week 2 post-radiation therapyPopulation: We only analyze available data
NCI-CTC(National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.
Outcome measures
| Measure |
HylaCare
n=27 Participants
Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.
|
Placebo
n=27 Participants
Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.
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|---|---|---|
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Acute Skin Toxicity Per NCI-CTC v4.0
Grade 0
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5 Participants
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3 Participants
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Acute Skin Toxicity Per NCI-CTC v4.0
Grade 1
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19 Participants
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23 Participants
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Acute Skin Toxicity Per NCI-CTC v4.0
Grade 2
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3 Participants
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1 Participants
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Acute Skin Toxicity Per NCI-CTC v4.0
Grade ≥ 3
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0 Participants
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0 Participants
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PRIMARY outcome
Timeframe: Week 5 during radiation therapyInvestigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with 0 = normal skin 1. = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema 2. = erythema with dry desquamation 3. = wet desquamation \</= 2 cm 4. = wet desquamation from 2.1 - 5cm 5. = wet desquamation from 5.1 - 9 cm 6. = wet desquamation \> 9.1 cm
Outcome measures
| Measure |
HylaCare
n=28 Participants
Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.
|
Placebo
n=28 Participants
Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.
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|---|---|---|
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Acute Skin Toxicity Per Investigator Grading Scale
Grade 0
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3 Participants
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4 Participants
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Acute Skin Toxicity Per Investigator Grading Scale
Grade 1
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18 Participants
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14 Participants
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Acute Skin Toxicity Per Investigator Grading Scale
Grade 2
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7 Participants
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10 Participants
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Acute Skin Toxicity Per Investigator Grading Scale
Grade ≥ 3
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0 Participants
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0 Participants
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PRIMARY outcome
Timeframe: Week 2 post-radiation therapyPopulation: We only analyzed data that were available
Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with 0 = normal skin 1. = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema 2. = erythema with dry desquamation 3. = wet desquamation \</= 2 cm 4. = wet desquamation from 2.1 - 5cm 5. = wet desquamation from 5.1 - 9 cm 6. = wet desquamation \> 9.1 cm
Outcome measures
| Measure |
HylaCare
n=27 Participants
Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.
|
Placebo
n=27 Participants
Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.
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|---|---|---|
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Acute Skin Toxicity Per Investigator Grading Scale
Grade 0
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4 Participants
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2 Participants
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Acute Skin Toxicity Per Investigator Grading Scale
Grade 1
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13 Participants
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12 Participants
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Acute Skin Toxicity Per Investigator Grading Scale
Grade 2
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10 Participants
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13 Participants
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Acute Skin Toxicity Per Investigator Grading Scale
Grade ≥3
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0 Participants
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0 Participants
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SECONDARY outcome
Timeframe: Week 5 during radiation therapyAcute skin toxicity, as measured by number of participants with skin reactions via self assessment
Outcome measures
| Measure |
HylaCare
n=28 Participants
Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.
|
Placebo
n=28 Participants
Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.
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|---|---|---|
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Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions
Skin reaction
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13 Participants
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7 Participants
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Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions
No Skin reaction
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15 Participants
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21 Participants
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Adverse Events
Expected Adverse Events With and Without Skin Cream(Hylacare)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Expected Adverse Events With and Without Skin Cream(Hylacare)
n=28 participants at risk
Expected adverse event due to radiation with and without the skin cream (Hylacare).
* Erythema
* Pain
* Tenderness
* Irritability
* Burning
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|---|---|
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Skin and subcutaneous tissue disorders
Desquamation
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50.0%
14/28 • Number of events 14 • The independent panel (two radiation oncologists and two breast surgeons) evaluated photographs of the breasts taken at week 5 during and 2 weeks post-RT
Expected adverse event due to radiation with and without the skin cream (Hylacare). * Erythema * Pain * Tenderness * Irritability * Burning * Dryness * Hypersensitivity * Hair loss
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place