StrataXRT for Radiation Dermatitis in Breast Cancer

Overseen By Edward LW Chow, MBBS

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

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test StrataXRT, a silicone-based gel, to determine its effectiveness in reducing skin problems caused by radiation therapy in breast cancer patients. These skin issues, known as radiation dermatitis, can include redness, itching, swelling, and even skin breakdown. The trial seeks patients with breast cancer who will receive specific types of radiation treatment to the chest area. Researchers believe that using StrataXRT during radiation therapy might lessen the severity of these skin reactions. As an unphased trial, this study offers patients the opportunity to contribute to research that could enhance skin care during 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 it excludes patients receiving cytotoxic chemotherapy. It's best to discuss your specific medications with the trial team.

What prior data suggests that StrataXRT is safe for treating radiation dermatitis in breast cancer patients?

Research has shown that StrataXRT is generally safe for patients. One study found it significantly reduces the risk of serious skin reactions during radiation treatment. Specifically, patients using StrataXRT had a 41% lower chance of developing moderate skin issues and a 49.4% lower chance of severe skin issues compared to those using other treatments. Another review found no additional safety concerns or harmful effects with StrataXRT. Overall, the treatment appears safe for managing skin problems from radiation therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

StrataXRT is unique because it offers a novel approach to managing radiation dermatitis in breast cancer patients. Unlike traditional treatments like topical corticosteroids or moisturizing creams, StrataXRT is a silicone-based gel specifically designed to form a protective barrier over the skin. This barrier not only helps to reduce inflammation and promote healing but also minimizes the chances of further irritation from radiation exposure. Researchers are excited about its potential to provide enhanced skin protection and comfort during radiation therapy, setting it apart from existing options.

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

Research has shown that StrataXRT might help manage skin irritation caused by radiation treatment in breast cancer patients. In one study with 100 participants, those who used StrataXRT experienced much less skin irritation than those who did not. Another study compared StrataXRT to a moisturizer called Xderm and found that StrataXRT significantly improved skin redness and changes in skin color. These results suggest that StrataXRT could help reduce skin problems from radiation therapy, but more research is needed to confirm these findings. In this trial, all participants will receive StrataXRT to further evaluate its effectiveness. ^{3 6 7 8 9}

Who Is on the Research Team?

Edward LW Chow, MBBS

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive StrataXRT during their radiation treatment, with weekly assessments

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2 weeks and 6 months post-treatment

6 months

1 visit (in-person) at 2 weeks, telephone follow-up at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• StrataXRT

Trial Overview 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.

How Is the Trial Designed?

Group I: StrataXRT Arm Experimental Treatment 1 Intervention

This is a single-arm trial where all patients will receive the intervention of StrataXRT.

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/39292351/

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

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05594498

NCT05594498 | A Study of StrataXRT in the Prevention ... Recent studies have shown the benefits of StrataXRT, but with mixed results. A recent randomized controlled trial published in 2022 found that in breast cancer ...

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

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

4. 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.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301624036563

StrataXRT and Mepitel Film for Preventing Postmastectomy ... This study evaluates the efficacy, safety, and user experience of StrataXRT versus Mepitel Film for ARD prevention.

6. 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 superior to moisturizer in delaying severity of skin toxicity: • Longer period without grade 3 skin toxicity with 75% of patients surviving 6 weeks ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31445838/

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 ...

8. 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 ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12361805/

Pilot evaluation of Mepitel Film and StrataXRT for the ... A systematic review and meta-analysis showed no additional safety concerns or toxicity issues associated with StrataXRT use. Other than the skin ...