HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Drug: HylaCare; Drug: Placebo

• Registration Number: NCT02165605
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-17
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Results First Submitted: 2019-09-11
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-28
• Last Update Submitted: 2020-09-28
• Results First Posted: 2020-10-22
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HylaCare	HylaCare	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	The patient is her own control.

Primary Outcome Measures

Name	Time	Method
Acute Skin Toxicity Per NCI-CTC v4.0	Week 2 post-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 2 post-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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States