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Completed

NCT Number: NCT02165605

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

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HylaCare

Drug

cream

Placebo

Drug

placebo

Primary outcomes

  1. Acute Skin Toxicity Per NCI-CTC v4.0

    Time frame: Week 5 during 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.

  2. Acute Skin Toxicity Per NCI-CTC v4.0

    Time frame: 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.

  3. Acute Skin Toxicity Per Investigator Grading Scale

    Time frame: Week 5 during radiation therapy

    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

  4. Acute Skin Toxicity Per Investigator Grading Scale

    Time frame: 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

    • = 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 outcomes

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

    Time frame: Week 5 during radiation therapy

    Acute skin toxicity, as measured by number of participants with skin reactions via self assessment

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 17, 2014
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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