What side effects are associated with this type of intervention?

Common treatments for radiation skin damage include topical corticosteroids, which can cause skin thinning, burning, and irritation; and topical antibiotics, which may lead to allergic reactions or antibiotic resistance. Moisturizers and emollients are generally well-tolerated but can occasionally cause mild skin irritation. Phototherapy, another treatment option, can result in burning, blistering, and pruritus. Proton pump inhibitors like esomeprazole, while primarily used for gastrointestinal issues, are being studied for their potential to reduce skin inflammation and damage, with side effects generally including headache, diarrhea, and abdominal pain.

What prior FDA approvals exist?

There are currently no specific FDA-approved treatments for radiation skin damage that are directly analogous to esomeprazole cream (Dermaprazole). However, various topical agents and therapies have been used to manage radiation dermatitis, including corticosteroids, hyaluronic acid, and other anti-inflammatory creams. These treatments aim to reduce inflammation, promote healing, and alleviate symptoms associated with radiation-induced skin damage.

What other types of research exist?

Promising alternatives to Esomeprazole Cream (Dermaprazole) for radiation skin damage include topical tacrolimus, pimecrolimus, and corticosteroids. These treatments have demonstrated efficacy in reducing inflammation and managing skin conditions, which may be beneficial for patients experiencing radiation-induced skin damage.

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Topical Dermaprazole for Radiation Skin Damage in Cancer Patients

Phase 1 & 2

Recruiting

Led By Michelle S Ludwig, MD, MPH, PhD

Research Sponsored by Michelle S Ludwig

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Arm B: Planned to receive adjuvant chest wall radiation of at least 40Gy or higher biologically equivalent dose (BED)

Arm A: Planned to receive concurrent chemoradiation with any radiosensitizing regimen of at least 60 Gy or higher

Must not have

Arm B: Biopsy-proven epidermal involvement or positive margins

Arm B: Any serious medical condition or illness that would preclude the safe administration of the study drug including, but not limited to: active infection, symptomatic heart failure, unstable angina, psychiatric illness or social situations that would limit compliance with treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at before and after dermaprazole cream application at the ct simulation visit, weekly during radiation treatment up to 7 weeks, 1 and 6 month follow-up after completion of all radiation therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a cream called Dermaprazole to prevent skin problems in patients receiving radiation therapy for head and neck or breast cancer. Patients will apply the cream throughout their radiation treatment. The study will check if the cream is safe and effective in reducing skin damage caused by radiation.

Who is the study for?

The TOPAZ trial is for adults with head and neck cancer or breast cancer who are undergoing radiation therapy. Eligible participants include those with specific types of these cancers, confirmed within the last 2 years, and planned to receive a certain dose of radiation. They must be in good enough health to participate as judged by their ECOG status. People can't join if they have had prior radiotherapy in the same area, are pregnant or breastfeeding, have certain medical conditions like active infections or collagen vascular diseases, allergies to proton pump inhibitors, or use specific medications.

What is being tested?

This study tests Dermaprazole cream at two different strengths (1% and 2%) for preventing skin damage caused by radiation therapy in patients with breast cancer post-mastectomy or head and neck cancer. The trial aims to assess how safe and tolerable this treatment is (Phase I) as well as its initial effectiveness (Phase II).

What are the potential side effects?

While not explicitly stated here, potential side effects may include local skin reactions such as irritation where the cream is applied since it's being tested for dermatitis prevention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for chest wall radiation of at least 40Gy.

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I am scheduled for chemoradiation with a high-dose plan.

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I am 18 years old or older.

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I am a woman who had breast cancer and underwent a type of mastectomy.

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I am 18 years old or older.

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I can care for myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My biopsy shows cancer on the skin or at the edge of the surgery area.

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I do not have any serious conditions that would make the study drug unsafe for me.

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I do not have any serious health issues that would make it unsafe for me to take the study drug.

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I have had radiotherapy to the chest before.

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I have had radiotherapy for head or neck cancer before.

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I am not currently receiving chemotherapy.

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I am currently taking clopidogrel, St. John's Wort, rifampin, or methotrexate.

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I have an active collagen vascular disease like lupus, scleroderma, or dermatomyositis.

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I have an open wound at the time of my treatment planning.

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I have an open wound from surgery that hasn't healed for more than 8 weeks.

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I have a condition like lupus, scleroderma, or dermatomyositis.

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I am currently taking clopidogrel, St. John's Wort, rifampin, or methotrexate.

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I am currently receiving chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at before and after dermaprazole cream application at the ct simulation visit, weekly during radiation treatment up to 7 weeks, 1 and 6 month follow-up after completion of all radiation therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at before and after dermaprazole cream application at the ct simulation visit, weekly during radiation treatment up to 7 weeks, 1 and 6 month follow-up after completion of all radiation therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and at before and after dermaprazole cream application at the ct simulation visit, weekly during radiation treatment up to 7 weeks, 1 and 6 month follow-up after completion of all radiation therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with Dose-Limiting Toxicity(DLT) in phase I

Rate of clinically bothersome radiation dermatitis at maximum feasible dose in phase II

Secondary study objectives

Median of the peak score of each QOL component

Median- occurrence time of grade 2 or higher acute radiation dermatitis

Median-healing time of grade 2 or higher acute radiation dermatitis develops

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dermaprazole 2% (Arm B: Breast)Experimental Treatment1 Intervention

Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.

Group II: Dermaprazole 2% (Arm A: Head and neck)Experimental Treatment1 Intervention

Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.

Group III: Dermaprazole 1% (ArmB: Breast)Experimental Treatment1 Intervention

Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.

Group IV: Dermaprazole 1% (Arm A:Head and neck)Experimental Treatment1 Intervention

Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Esomeprazole cream (Dermaprazole), a proton pump inhibitor, is being studied for its potential to reduce skin inflammation and damage in radiation dermatitis. PPIs like esomeprazole may help by inhibiting proton pumps, which can reduce the production of pro-inflammatory cytokines and oxidative stress, thereby mitigating skin damage. This is particularly important for radiation skin damage patients as it addresses the underlying inflammation and promotes healing. Other common treatments include topical corticosteroids, which reduce inflammation and immune response, and emollients, which maintain skin hydration and barrier function. Together, these treatments aim to alleviate symptoms, reduce inflammation, and promote skin repair, improving the quality of life for patients undergoing radiation therapy.