Efficacy Study With StrataXRT for the Prophylaxis of Radiation Dermatitis in Adjuvant Breast Radiation Treatment in Large Breasted Women Using a Prone Technique
StrataXRT: StrataXRT being a silicone-based cream forming a film, it is very flexible and can be applied easily to the prone position and to the contours of the large breast unlike some other barrier film skin interventions
Study 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. 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Acute toxicity as defined by the CTCAE V5 assessed by HCP — 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. CTCAE Dermatitis Grade:
0 No symptoms
1. Faint erythema or dry desquamation
2. Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin fold and creases; moderate edema
3. Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
4. Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated
5. Death
Trial sites (1)
Facility
City
Region
Status
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto
Ontario
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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