What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those aimed at managing radiation dermatitis, include radiation therapy and topical treatments like StrataXRT. Radiation therapy can cause side effects such as erythema, pruritus, edema, and in severe cases, moist desquamation. Topical treatments like StrataXRT, which is a silicone-based gel, are generally well-tolerated but can occasionally cause skin irritation or allergic reactions. Systemic treatments like chemotherapy and endocrine therapy (e.g., tamoxifen, aromatase inhibitors) can lead to side effects such as alopecia, nausea, fatigue, and increased risk of infections. Endocrine therapies may also cause bone density loss and cardiovascular issues.

What prior FDA approvals exist?

The FDA has approved several treatments for managing side effects of radiation therapy in breast cancer patients, although specific approvals for silicone-based film-forming topical gels like StrataXRT are not well-documented. Commonly approved treatments include various topical corticosteroids and moisturizers to alleviate radiation dermatitis. Additionally, other supportive care measures such as oral medications for pain and inflammation, and advanced wound care products, have been approved to manage severe skin reactions resulting from radiation therapy.

What other types of research exist?

Promising alternatives to StrataXRT for reducing radiation dermatitis in breast cancer patients include: 1) Xderm, a moisturizer cream, which has shown significant differences in reducing erythema and melanin indices compared to StrataXRT. 2) Mepitel Film, a soft silicone dressing that has demonstrated effectiveness in preventing radiation-induced skin reactions. 3) Calendula officinalis, a topical agent that has been studied for its anti-inflammatory properties and potential to reduce radiation dermatitis severity. Patients should discuss these options with their healthcare provider to determine the best course of action based on individual needs and treatment plans.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3-months following radiation treatment for reporting.

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 more

Awards & 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

Do I qualify?Apply below to find out

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.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

673 Previous Clinical Trials

1,565,822 Total Patients Enrolled

30 Trials studying Breast Cancer

17,037 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

~15 spots leftby Oct 2025

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