StrataXRT for Radiation Burn

Recruiting in Palo Alto (17 mi)

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?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.

Eligibility Criteria

This trial is for large-breasted women with breast cancer who are receiving adjuvant radiation therapy. It's specifically looking at those using a prone technique to reduce skin reactions. Participants must meet certain health criteria, but specific inclusion and exclusion details aren't provided.

Inclusion Criteria

I am 18 years old or older.

My bra size is 40 inches or larger and/or my cup size is D or larger.

Informed consent

+4 more

Exclusion Criteria

I cannot lie on my stomach for a long time.

I will receive targeted radiation therapy for my breast.

I have had radiation therapy on the area being treated.

+6 more

Participant Groups

The study tests StrataXRT, a silicone-based gel, to see if it can prevent or lessen radiation dermatitis—a common side effect of radiation treatment that causes skin irritation and breakdown—in these patients.

1Treatment groups

Experimental Treatment

Group I: StrataXRTExperimental Treatment1 Intervention

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.