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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | The patient is her own control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HylaCare | Drug | cream |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 5 during radiation therapy |
| 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. | Week 2 post-radiation therapy |
| 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
| Week 5 during radiation therapy |
| 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
| Week 2 post-radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 5 during radiation therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asal Rahimi, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31273506 | Derived | Rahimi A, Mohamad O, Albuquerque K, Kim DWN, Chen D, Thomas K, Wooldridge R, Rivers A, Leitch M, Rao R, Haley B, Ahn C, Garwood D, Spangler A. Novel hyaluronan formulation for preventing acute skin reactions in breast during radiotherapy: a randomized clinical trial. Support Care Cancer. 2020 Mar;28(3):1481-1489. doi: 10.1007/s00520-019-04957-0. Epub 2019 Jul 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 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. | 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. | Posted | Count of Participants | Participants | Week 5 during radiation therapy |
|
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).
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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 | Expected Adverse Events With and Without Skin Cream(Hylacare) | Expected adverse event due to radiation with and without the skin cream (Hylacare).
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment | HA serum: 6 participants (21%) Placebo: 8 participants (29%) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarmistha Sen | UT Southwestern Medical Center | 214-645-1477 | Sarmistha.Sen@UTSouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 7, 2014 | Sep 18, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Drug |
placebo |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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 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. |
|
|
| 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. | We only analyze available data | Posted | Count of Participants | Participants | Week 2 post-radiation therapy |
|
|
|
| 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
| Posted | Count of Participants | Participants | Week 5 during radiation therapy |
|
|
|
| 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
| We only analyzed data that were available | Posted | Count of Participants | Participants | Week 2 post-radiation therapy |
|
|
|
| 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 | Posted | Count of Participants | Participants | Week 5 during radiation therapy |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 14 |
| 28 |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Grade 2 |
|
| Grade ≥ 3 |
|
| Grade 2 |
|
| Grade ≥ 3 |
|
| Grade 2 |
|
| Grade ≥3 |
|