Efficacy Study With StrataXRT for the Prophylaxis of Radiation Dermatitis in Adjuvant Breast Radiation Treatment in Large Breasted Women Using a Prone Technique

NCT06865131 | Active Not Recruiting

• 1 other identifier: StrataXRT Prone
• Study Type: interventional
• Target: 20
• 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. 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

Breast Cancer; Radiation Dermatitis

Keywords

Barrier cream; StrataXRT; Prophylaxis; Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• Acute toxicity as defined by the CTCAE V5 assessed by HCP

  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

  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.

Secondary Outcomes (7)

• Incidence of moist desquamation 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.

• Radiation-Induced Skin Reaction Assessment Scale (RISRAS) assessed by patient and 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.

• Photographs of treated and non-treated breast/chest wall for blind and unbiased assessment of the skin by HCPs

  At baseline when the patient is first recruited, the last treatment day of radiation (3-5 weeks after the first day of radiation depending on radiation dose/fractionation) and at 2 weeks follow up after the end of radiation.

• Patient-reported QOL using the Skindex-16

  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.

• Patient satisfaction with StrataXRT as assessed by the patient satisfaction questionnaire

  During 3 months following radiation

Study Arms (1)

StrataXRT

EXPERIMENTAL

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.

Device: StrataXRT

Interventions

StrataXRT DEVICE

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

StrataXRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

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 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: Co-Principle Investigator with Dr. Irene Karam [ikaram]

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: March 7, 2025
• Study Start: February 14, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 3, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)