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

NCT02165605 | Completed Results DMC

• 1 other identifier: STU 092012-058
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

external beam radiotherapy; breast cancer

Outcome Measures

Primary Outcomes (4)

• 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 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

  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 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

  Week 2 post-radiation therapy

Secondary Outcomes (1)

• Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions

  Week 5 during radiation therapy

Study Arms (2)

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.

Drug: HylaCare

Placebo

PLACEBO COMPARATOR

The patient is her own control.

Drug: Placebo

Interventions

HylaCare DRUG

cream

HylaCare

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75239, United States

Location

Related Publications (1)

• 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.

  PMID: 31273506 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Sarmistha Sen
• Organization: UT Southwestern Medical Center

Sarmistha.Sen@UTSouthwestern.edu

214-645-1477

Study Officials

• Asal Rahimi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: June 17, 2014
• Study Start: August 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-09

Locations

US (1)