StrataXRT Arm for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+1 MoreStrataXRT - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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. 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.

Eligible Conditions
  • Breast Cancer
  • Radiation Skin Damage

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Within 3-months following radiation treatment

Within 3-months following radiation treatment
Acute Coryza
Clinician satisfaction with StrataXRT
Acute Coryza
Cost analysis of StrataXRT
Degree of acute skin toxicity and interference with daily functioning
Incidence of moist desquamation
Breast
Patient reports of acute toxicity
Patient satisfaction with StrataXRT
Patient-reported quality of life

Trial Safety

Trial Design

1 Treatment Group

StrataXRT Arm
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: StrataXRT Arm · No Placebo Group · N/A

StrataXRT Arm
Device
Experimental Group · 1 Intervention: StrataXRT · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 3-months following radiation treatment

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
604 Previous Clinical Trials
1,469,137 Total Patients Enrolled
25 Trials studying Breast Cancer
12,676 Patients Enrolled for Breast Cancer
Edward LW Chow, MBBSPrincipal InvestigatorSunnybrook Health Sciences Centre
2 Previous Clinical Trials
246 Total Patients Enrolled
2 Trials studying Breast Cancer
246 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are scheduled to receive conventionally or hypofractionated radiation therapy.