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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called StrataXRT, a silicone-based gel, to determine if it reduces skin issues caused by radiation therapy in breast cancer patients. These skin problems can include redness, itching, and, in severe cases, skin breaking. The trial seeks women with large breasts who have breast cancer and will receive radiation therapy while lying on their stomachs. Participants will apply the gel twice daily during and after their radiation treatment to assess its effectiveness in preventing or lessening these skin reactions. As an unphased trial, this study allows participants to contribute to research that could enhance comfort and outcomes for future patients undergoing radiation therapy.

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 prior data suggests that StrataXRT is safe for treating radiation dermatitis?

Research has shown that StrataXRT is generally safe and well-tolerated by patients. In past studies, this silicone-based gel effectively managed skin problems such as redness, itching, and swelling caused by radiation therapy. Importantly, these studies reported no major side effects, suggesting that StrataXRT is safe for use on skin affected by radiation. Patients in these studies applied the gel twice a day, which helped reduce the severity of their skin reactions. Therefore, for those considering joining a trial with StrataXRT, existing evidence supports its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike other treatments for radiation burns, StrataXRT is a topical gel specifically designed to support skin healing when it's most vulnerable during and after radiation therapy. Most current treatments rely on general wound care products like aloe vera gels or corticosteroid creams, which provide soothing relief but do not specifically target the unique needs of radiation-damaged skin. StrataXRT is unique because it forms a protective film over the affected area, helping to maintain a moist healing environment crucial for skin recovery. Researchers are excited about StrataXRT because it promises a more targeted approach, potentially reducing the severity of radiation burns and improving patient comfort during a difficult treatment phase.

What evidence suggests that StrataXRT might be an effective treatment for radiation dermatitis?

Research has shown that StrataXRT can help reduce skin problems such as redness, itching, and peeling in breast cancer patients undergoing radiation therapy. Studies have found that it lowers the risk of severe skin reactions by up to 49.4%. In this trial, all participants will receive StrataXRT to evaluate its effectiveness in preventing serious skin issues. Notably, previous studies indicated that patients using StrataXRT while lying face down experienced the best results. These findings suggest that StrataXRT could be a helpful option for managing skin side effects during radiation therapy. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37556002/

StrataXRT for the prevention of acute radiation dermatitis in ... Conclusion: StrataXRT may help prevent severe acute RD in breast cancer RT patients. Further high quality, large-scale studies are needed to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05073172

StrataXRT for the Prevention and Treatment of Radiation ... This clinical trial studies the effect of StrataXRT in preventing and treating radiation dermatitis in breast cancer or head and neck cancer patients.

3. us.strataxrt.com us.strataxrt.com/clinical-efficacy/

Clinical efficacy in radiation dermatitis treatment “StrataXRT was not inferior to Mepitel Film on the reported outcome measures of occurrence of moist desquamation, worst grade of acute radiation dermatitis ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S016781401933004X

A single-blind, randomised controlled trial of StrataXRT® – ... Cox regression analysis showed that patients receiving StrataXRT® had a 41.0% and 49.4% reduced risks of developing grade 2 and 3 skin toxicity respectively ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39292351/

StrataXRT for the prevention of acute radiation dermatitis in ... Conclusion: StrataXRT is effective in preventing grade 3 RD in patients, and the most promising results were observed within the prone cohort.

6. us.strataxrt.com us.strataxrt.com/strataxrt/

StrataXRT wound dressing for radiation dermatitis StrataXRT is recommended to be used following the initial radiation dose and should be applied continuously for a minimum of 60–90 days (24 hours a day / 7 days ...

7. us.strataxrt.com us.strataxrt.com/wp-content/uploads/2020/07/StrataXTR-DetailAid-RX-V7.pdf

A new approach in the management of radiation dermatitis StrataXRT is indicated for use on all types of radiation dermatitis, toxic and compromised skin and superficial wounds resulting from radiation therapy.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6984096/

Reducing Radiation Dermatitis Using a Film-forming Silicone ... Studies have raised the possibility that topical use of StrataXRT might be effective in reducing various types of radiation-induced skin reactions (27,28). A ...