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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HylaCare
Placebo
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring external beam radiotherapy, breast cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HylaCare

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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
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

Secondary Outcome Measures

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

Full Information

First Posted
December 19, 2013
Last Updated
September 28, 2020
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02165605
Brief Title
HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
external beam radiotherapy, breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HylaCare
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The patient is her own control.
Intervention Type
Drug
Intervention Name(s)
HylaCare
Intervention Description
cream
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Acute Skin Toxicity Per NCI-CTC v4.0
Description
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
Title
Acute Skin Toxicity Per NCI-CTC v4.0
Description
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
Title
Acute Skin Toxicity Per Investigator Grading Scale
Description
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
Time Frame
Week 5 during radiation therapy
Title
Acute Skin Toxicity Per Investigator Grading Scale
Description
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
Time Frame
Week 2 post-radiation therapy
Secondary Outcome Measure Information:
Title
Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions
Description
Acute skin toxicity, as measured by number of participants with skin reactions via self assessment
Time Frame
Week 5 during radiation therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asal Rahimi, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31273506
Citation
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.
Results Reference
derived

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

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