Clinical trial · Interventional
Efficacy Study With StrataXRT for the Prophylaxis of Radiation Dermatitis in Adjuvant Breast Radiation Treatment in Large Breasted Women Using a Prone Technique
- 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. In a study published it was found that for women with large breasts (n=357), being positioned in the supine position during radiation could lower the rates of moist desquamation from 36.9% in the supine position down to 26.9% when treated in the prone position. Even though the prone position for patients with large breasts did reduce rates of moist desquamation, these results demonstrate that one in five patients still go on to develop severe reactions, even in the prone position. Building on these results, a phase II feasibility study conducted at Sunnybrook, found that the use of a silicone-based film forming topical gel known as StrataXRT could lower the incidence of moist desquamation for patients treated in the prone position even further.
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
- description
- All patients will receive StrataXRT for the duration of their treatment. RT will be delivered as prescribed by the treating radiation oncologist and may include a variety of techniques and beam modifiers. A trained CRA will teach the patient how to apply StrataXRT prior to their first RT at a designated clinic room and will perform daily checks prior to radiation for the first week of treatment to ensure that the patient has covered the entire treatment area. StrataXRT will be used by the patients daily during their entire treatment, and for a minimum of 2 weeks post-RT. As recommended by the product monograph, patients will be asked to apply StrataXRT twice daily, once in the morning and once in the evening. Additionally, as suggested in the monograph, patients will be directed to reapply the gel any time after they take a shower or if they notice the film is no longer covering the treatment area.
- interventionNames
- Device: StrataXRT
Primary outcomes (1)
- measure
- Acute toxicity as defined by the CTCAE V5 assessed by HCP
- timeFrame
- Once per week during radiation in the treating radiation oncologist's review clinic, and within 3 months following radiation. Radiation treatment duration varies depending on dosage/fractionation, but ranges from 3 to 5 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old * Informed consent * Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes * Patients are scheduled to receive conventionally - (50 Gy/25) or hypofractionated (40 Gy/15) RT to the breast only in the prone position. * Women with large breasts equivalent to ≥40-inch band size and/or cup size ≥D * Patients treated with or without the addition of boost. * Can communicate in English or be aided by a translator Exclusion Criteria: * Patients unable to lie prone for the duration of radiation treatment * Patient had previous radiation therapy to the treatment area * Patients receiving locoregional radiation treatment * 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 (0)
Data not yet available