A Study of StrataXRT in the Prevention of Radiation Dermatitis in Breast Cancer Patients

NCT05594498 | Active Not Recruiting

• 1 other identifier: StrataXRT
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

For breast cancer patients undergoing adjuvant radiotherapy, radiation dermatitis (RD) is a common occurrence that can negatively impact patients' quality of life (QOL). RD often presents as erythema, pruritus, and/or edema and in more severe cases, skin breakage can occur, resulting in moist desquamation. StrataXRT is a silicone-based film-forming topical gel. Recent studies have shown the benefits of StrataXRT, but with mixed results. A recent randomized controlled trial published in 2022 found that in breast cancer patients (n=100), the use of StrataXRT significantly reduced the mean size of the radiation-induced dermatitis area (p=0.002) when compared to the control group. Additionally, another study (n=49) demonstrated significant differences in the Erythema Index (EI) (p=0.001) and Melanin Index (MI) (p=0.005) between StrataXRT compared to the use of Xderm, a moisturizer cream. To validate the finding of the previous studies a pilot study testing the efficacy of StrataXRT has been proposed. In this study, 50 patients will use Strata XRT on their breast/chest wall during radiation treatment. Their skin will be assessed throughout and post-treatment. Investigators hypothesize the severity of skin reactions will be less for patients using Strata XRT when compared to historical data from our centre.

Conditions

Breast Cancer; Radiation Dermatitis

Keywords

Skin toxicity; StrataXRT; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Clinician grading of acute skin toxicity

  Measured by the Common Terminology Criteria for Adverse Events; graded on a scale from 0 (best) to 4 (worst) assessed by clinicians

  Within 3-months following radiation treatment

Secondary Outcomes (9)

• Patient reports of acute toxicity

  Within 3-months following radiation treatment

• Clinicians reports of acute toxicity

  Within 3-months following radiation treatment

• Incidence of moist desquamation

  Within 3-months following radiation treatment

• Degree of acute skin toxicity and interference with daily functioning

  Within 3-months following radiation treatment

• Observable differences between treated and non-treated breasts/chest wall

  Within 3-months following radiation treatment

Study Arms (1)

StrataXRT Arm

EXPERIMENTAL

This is a single-arm trial where all patients will receive the intervention of StrataXRT.

Device: StrataXRT

Interventions

StrataXRT DEVICE

StrataXRT is a silicone-based film-forming topical gel that may help in reducing radiation dermatitis.

StrataXRT Arm

Eligibility Criteria

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

You may qualify if:

• Informed consent
• Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes
• Patient are scheduled to receive conventionally - (50 Gy/25) or hypofractionated (40 Gy/15 or 42.6 Gy/16)
• Can communicate in English or be aided by a translator

You may not qualify if:

• Patient had previous radiation therapy to the treatment area
• Patient will receive partial breast external beam radiation or brachytherapy
• Patients scheduled to receive extreme hypofractionation (26 Gy/ 5)
• Patients with active rash, pre-existing dermatitis, or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion.
• Patients with known allergy or sensitivity to silicone
• Concomitant cytotoxic chemotherapy
• Bilateral breast pathology requiring concurrent bilateral breast radiation

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (3)

• Ahn S, Sung K, Kim HJ, Choi YE, Lee YK, Kim JS, Lee SK, Roh JY. Reducing Radiation Dermatitis Using a Film-forming Silicone Gel During Breast Radiotherapy: A Pilot Randomized-controlled Trial. In Vivo. 2020 Jan-Feb;34(1):413-422. doi: 10.21873/invivo.11790.

  PMID: 31882508 BACKGROUND

• Kuszaj O, Day M, Zhang L, Wong H, Lee SF, Kwan JYY, Wang AJ, Bayrakdarian S, Karam I, Tran W, Chow E. Validation of the Skin Symptom Assessment (SSA) questionnaire for the evaluation of radiation dermatitis in breast cancer patients. Support Care Cancer. 2024 Sep 24;32(10):683. doi: 10.1007/s00520-024-08890-9.

  PMID: 39316164 DERIVED

• Kennedy SKF, Gojsevic M, Rajeswaran T, Zhang L, Kuszaj O, Day M, Karam I, Vesprini D, Leung E, Szumacher E, Rakovitch E, Soliman H, Chen H, Lee SF, Behroozian T, Tran W, Wronski M, Gallant F, Carothers K, Yewhans T, Wong C, Wong H, Chow E. StrataXRT for the prevention of acute radiation dermatitis in breast cancer: a pilot study. Support Care Cancer. 2024 Sep 18;32(10):670. doi: 10.1007/s00520-024-08851-2.

  PMID: 39292351 DERIVED

Related Links

• StrataXRT is non-inferior to Mepitel Film
• The Investigation of Prophylactic Effect of StrataXRT Gel on Radiation-Induced Dermatitis in Breast Cancer Patients: A Randomized Clinical Trial

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Study Officials

• Edward LW Chow, MBBS

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patients will receive the StrataXRT intervention. StrataXRT will be given to patients in one of five patient populations: 1. Patients with large breasts (minimum of band size of 36 inches or cup size C) treated in the prone position-breast radiation only 2. Patients with large breasts (minimum of band size of 36 inches or cup size C) treated in the supine position---breast radiation only 3. Patients with locoregional breast radiation (any breast size) 4. Patients with local chest wall radiation alone 5. Patients with locoregional chest wall radiation

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 26, 2022
• Study Start: October 13, 2022
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

CA (1)