Clinical trial · Interventional
A Study of StrataXRT in the Prevention of Radiation Dermatitis in Breast Cancer Patients
A Pilot Study of StrataXRT in the Prevention of Radiation Dermatitis in Breast Cancer Patients Undergoing Adjuvant Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| StrataXRT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- StrataXRT Arm
- description
- This is a single-arm trial where all patients will receive the intervention of StrataXRT.
- interventionNames
- Device: StrataXRT
Primary outcomes (1)
- measure
- Clinician grading of acute skin toxicity
- timeFrame
- Within 3-months following radiation treatment
- description
- Measured by the Common Terminology Criteria for Adverse Events; graded on a scale from 0 (best) to 4 (worst) assessed by clinicians
Secondary outcomes (9)
- measure
- Patient reports of acute toxicity
- timeFrame
- Within 3-months following radiation treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (3)
- BACKGROUNDAhn 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
- DERIVEDKuszaj 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
- DERIVEDKennedy 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