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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

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

Study Summary

This trial is studying a prophylactic cream to see if it can help prevent skin damage caused by radiation therapy in patients with breast or head and neck cancer.

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.Check my eligibility

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).See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 6Eligibility criteria met

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Who is running the clinical trial?

Michelle S LudwigLead Sponsor

1 Previous Clinical Trials

24 Total Patients Enrolled

Michelle S Ludwig, MD, MPH, PhDPrincipal InvestigatorBaylor College of Medicine

1 Previous Clinical Trials

24 Total Patients Enrolled

Media Library

Dermaprazole 1% Clinical Trial Eligibility Overview. Trial Name: NCT05269160 — Phase 1 & 2

Radiation Skin Damage Research Study Groups: Dermaprazole 1% (Arm A:Head and neck), Dermaprazole 2% (Arm B: Breast), Dermaprazole 2% (Arm A: Head and neck), Dermaprazole 1% (ArmB: Breast)

Radiation Skin Damage Clinical Trial 2023: Dermaprazole 1% Highlights & Side Effects. Trial Name: NCT05269160 — Phase 1 & 2

Dermaprazole 1% 2023 Treatment Timeline for Medical Study. Trial Name: NCT05269160 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still spots available for volunteers in this research project?

"Unfortunately, this study is not currently accepting patients. Although the trial was last updated on September 14th, 2022, it was originally posted on December 1st, 20212. There are 3387 other clinical trials that are still recruiting patients."

Answered by AI

What are the aims of this experiment?

"The purpose of this clinical trial, which will be conducted over the course of 7 weeks with weekly evaluations, is to study the effect of the medication on patients. The primary outcome measure is the number of participants who experience dose-limiting toxicity. Secondary outcomes include median healing time for grade 2 or higher acute radiation dermatitis, rate of occurrence for grade 2 or higher acute radiation dermatitis, and rate of grade 2 or higher acute radiation dermatitis."

Answered by AI

Am I eligible to participate in this research?

"This study is recruiting 57 patients with breast cancer who are aged 18-100. Participants must also meet the following criteria: Arm B: Breast cancer arm, Histological diagnosis of invasive ductal or lobular carcinoma (diagnosed within 2 years of enrollment), Planned to receive adjuvant chest wall radiation of at least 40Gy or higher biologically equivalent dose (BED), Age 18 years or older, Written Informed Consent, History and Physical within 12 weeks of enrollment, Arm A: Head & Neck cancer arm, Patients with squamous cell carcinoma of the head and neck confirmed with institutional pathology (diagnosed within 2 years"

Answered by AI