StrataXRT for Radiation Burn

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Cytotoxic chemotherapy

Disqualifiers: Previous radiation, Active rash, Others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving cytotoxic chemotherapy (a type of cancer treatment that uses drugs to kill cancer cells).

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

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

Informed consent

I have received treatment with or without an extra dose.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive adjuvant breast radiation treatment using a prone technique, with StrataXRT applied daily

3-5 weeks

Daily visits for radiation treatment

Post-Treatment

Participants continue to apply StrataXRT for a minimum of 2 weeks post-radiation

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of radiation dermatitis and quality of life

3 months

Weekly visits during radiation, follow-up visits at 2 weeks and 3 months post-radiation

Treatment Details

Interventions

• StrataXRT

Trial Overview 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.

Participant Groups

Group I: StrataXRT Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+