Breast Cancer
Conditions
Keywords
external beam radiotherapy, breast cancer
Brief summary
This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness and safety of HylaCareTM. The study will employ the patient as her own control, a commonly used method for the evaluation of topical dermatologic agents. 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.
Detailed description
Patients will be allocated to the treatment using a randomized permuted block. There will be no stratification. Patients will be randomized to receive the investigational product to be applied to either the medial (inside) or lateral (outside) portion of the breast, a placebo product will be used on the other side. Patients and clinical investigators will be blinded to the treatment assignments.
Interventions
DRUGHylaCare
cream
DRUGPlacebo
placebo
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Female, age 18 or older * Diagnosis of breast cancer * Intact breast (not surgically absent) * Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions) * Ability to understand and comply with the requirements of this study * Ability to give Informed Consent * For sexually active females, patient agrees to use acceptable method of birth control
Exclusion criteria
* Women who are pregnant or lactating * Use of concomitant skin care preparations at any of the treated or control portal areas to be observed * Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis * Severe renal failure creatinine \> 3.0 within 6 months of study registration * Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo * Planned relocation which would make follow-up visits impossible during the course of the study * Collagen vascular disease such as Lupus, or scleroderma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Skin Toxicity Per NCI-CTC v4.0 | Week 5 during radiation therapy | 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. |
| Acute Skin Toxicity Per Investigator Grading Scale | Week 5 during radiation therapy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions | Week 5 during radiation therapy | Acute skin toxicity, as measured by number of participants with skin reactions via self assessment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hylacare-Experimental 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. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Hylacare-Experimental |
|---|---|
| Age, Continuous | 60 years |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 14 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Acute Skin Toxicity Per Investigator Grading Scale
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
Time frame: Week 5 during radiation therapy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HylaCare | Acute Skin Toxicity Per Investigator Grading Scale | Grade 1 | 18 Participants |
| HylaCare | Acute Skin Toxicity Per Investigator Grading Scale | Grade 0 | 3 Participants |
| HylaCare | Acute Skin Toxicity Per Investigator Grading Scale | Grade 2 | 7 Participants |
| HylaCare | Acute Skin Toxicity Per Investigator Grading Scale | Grade ≥ 3 | 0 Participants |
| Placebo | Acute Skin Toxicity Per Investigator Grading Scale | Grade ≥ 3 | 0 Participants |
| Placebo | Acute Skin Toxicity Per Investigator Grading Scale | Grade 2 | 10 Participants |
| Placebo | Acute Skin Toxicity Per Investigator Grading Scale | Grade 0 | 4 Participants |
| Placebo | Acute Skin Toxicity Per Investigator Grading Scale | Grade 1 | 14 Participants |
Primary
Acute Skin Toxicity Per Investigator Grading Scale
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
Time frame: Week 2 post-radiation therapy
Population: We only analyzed data that were available
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HylaCare | Acute Skin Toxicity Per Investigator Grading Scale | Grade 0 | 4 Participants |
| HylaCare | Acute Skin Toxicity Per Investigator Grading Scale | Grade 1 | 13 Participants |
| HylaCare | Acute Skin Toxicity Per Investigator Grading Scale | Grade 2 | 10 Participants |
| HylaCare | Acute Skin Toxicity Per Investigator Grading Scale | Grade ≥3 | 0 Participants |
| Placebo | Acute Skin Toxicity Per Investigator Grading Scale | Grade ≥3 | 0 Participants |
| Placebo | Acute Skin Toxicity Per Investigator Grading Scale | Grade 0 | 2 Participants |
| Placebo | Acute Skin Toxicity Per Investigator Grading Scale | Grade 2 | 13 Participants |
| Placebo | Acute Skin Toxicity Per Investigator Grading Scale | Grade 1 | 12 Participants |
Primary
Acute Skin Toxicity Per NCI-CTC v4.0
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.
Time frame: Week 5 during radiation therapy
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HylaCare | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade 0 | 3 Participants |
| HylaCare | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade 1 | 19 Participants |
| HylaCare | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade ≥3 | 0 Participants |
| HylaCare | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade 2 | 6 Participants |
| Placebo | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade ≥3 | 0 Participants |
| Placebo | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade 0 | 3 Participants |
| Placebo | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade 1 | 18 Participants |
| Placebo | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade 2 | 7 Participants |
Primary
Acute Skin Toxicity Per NCI-CTC v4.0
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.
Time frame: Week 2 post-radiation therapy
Population: We only analyze available data
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HylaCare | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade 0 | 5 Participants |
| HylaCare | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade 1 | 19 Participants |
| HylaCare | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade 2 | 3 Participants |
| HylaCare | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade ≥ 3 | 0 Participants |
| Placebo | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade ≥ 3 | 0 Participants |
| Placebo | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade 0 | 3 Participants |
| Placebo | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade 2 | 1 Participants |
| Placebo | Acute Skin Toxicity Per NCI-CTC v4.0 | Grade 1 | 23 Participants |
Secondary
Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions
Acute skin toxicity, as measured by number of participants with skin reactions via self assessment
Time frame: Week 5 during radiation therapy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HylaCare | Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions | Skin reaction | 13 Participants |
| HylaCare | Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions | No Skin reaction | 15 Participants |
| Placebo | Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions | Skin reaction | 7 Participants |
| Placebo | Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions | No Skin reaction | 21 Participants |