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

Randomized, Double-Blind, Vehicle-Controlled Pilot Study of the Efficacy and Safety of HylaCareTM in the Treatment of Acute Skin Changes in Patients Undergoing External Beam Radiotherapy for Tumors of the Breast.

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Placebo; Drug: HylaCare

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75239
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: HylaCare; cream
Placebo Comparator: Placebo; The patient is her own control.	Drug: Placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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; = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema; = erythema with dry desquamation; = wet desquamation </= 2 cm; = wet desquamation from 2.1 - 5cm; = wet desquamation from 5.1 - 9 cm; = wet desquamation > 9.1 cm	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; = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema; = erythema with dry desquamation; = wet desquamation </= 2 cm; = wet desquamation from 2.1 - 5cm; = wet desquamation from 5.1 - 9 cm; = wet desquamation > 9.1 cm	Week 2 post-radiation therapy

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Asal Rahimi, MD, University of Texas Southwestern Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: breast cancer; external beam radiotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: STU 092012-058