Clinical trial NCT02165605: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: external beam radiotherapy
breast cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Acute Skin Toxicity Per NCI-CTC v4.0
timeFrame: Week 5 during radiation therapy
measure: Acute Skin Toxicity Per NCI-CTC v4.0
timeFrame: Week 2 post-radiation therapy
measure: Acute Skin Toxicity Per Investigator Grading Scale
timeFrame: Week 5 during radiation therapy
measure: Acute Skin Toxicity Per Investigator Grading Scale
timeFrame: Week 2 post-radiation therapy
Secondary outcomes:
measure: Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions
timeFrame: Week 5 during radiation therapy
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Asal Rahimi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.