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StrataXRT for Radiation Dermatitis in Breast Cancer
N/A
Waitlist Available
Led By Edward LW Chow, MBBS
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 3-months following radiation treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial tests StrataXRT, a gel that forms a protective film on the skin, for breast cancer patients undergoing radiation therapy. The gel aims to prevent skin problems caused by radiation by creating a protective barrier. StrataXRT has been previously evaluated for its effectiveness in reducing skin issues in breast cancer patients.
Who is the study for?
This trial is for breast cancer patients who can communicate in English (or with a translator), have confirmed breast malignancy or phyllodes, and are set to receive standard or hypofractionated radiotherapy. It's not for those allergic to silicone, undergoing cytotoxic chemotherapy, extreme hypofractionation, bilateral radiation at the same time, partial breast radiation/brachytherapy, or with pre-existing skin conditions.
What is being tested?
The study tests StrataXRT—a silicone-based gel—on its effectiveness in preventing radiation dermatitis during adjuvant radiotherapy for breast cancer. The hypothesis is that using StrataXRT will result in less severe skin reactions compared to previous data from similar treatments.
What are the potential side effects?
While specific side effects of StrataXRT aren't detailed here, it may include potential skin irritation or allergic reactions given its topical application. Patients with known sensitivity to silicone were excluded suggesting possible adverse reactions related to this ingredient.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 3-months following radiation treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 3-months following radiation treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acute Coryza
Secondary study objectives
Clinician satisfaction with StrataXRT
Acute Coryza
Cost analysis of StrataXRT
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: StrataXRT ArmExperimental Treatment1 Intervention
This is a single-arm trial where all patients will receive the intervention of StrataXRT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
StrataXRT
2017
N/A
~450
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Breast cancer treatments work through various mechanisms to target and destroy cancer cells or alleviate treatment side effects. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells.
Hormone therapy blocks hormones like estrogen that can promote cancer growth in hormone receptor-positive breast cancers. Targeted therapies, such as HER2 inhibitors, specifically target cancer cell proteins to inhibit their growth.
StrataXRT, a silicone-based film-forming topical gel, creates a protective barrier on the skin to reduce the severity of radiation dermatitis, a common side effect of radiotherapy. This matters for breast cancer patients as it can significantly improve their quality of life by minimizing skin damage and discomfort during treatment.
Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: a phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4.
Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: a phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4.
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
680 Previous Clinical Trials
1,565,821 Total Patients Enrolled
31 Trials studying Breast Cancer
17,097 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