StrataXRT for Radiation Dermatitis in Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byEdward LW Chow, MBBS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

You have been fully informed about the study and have given your permission to participate.

Can communicate in English or be aided by a translator

Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes

+1 more

Exclusion Criteria

You have an allergy or sensitivity to silicone.

You are currently receiving chemotherapy treatment.

Patients scheduled to receive extreme hypofractionation (26 Gy/ 5)

+4 more

Participant Groups

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.

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.