Topical Dermaprazole for Radiation Dermatitis in Breast Cancer and Head and Neck Cancer Patients (TOPAZ)
Radiotherapy is a mainstay of treatment in head and neck cancer and breast cancer treatment, typically following surgery and/or chemotherapy. Radiation dermatitis, which involves redness, dryness, and/or peeling of the skin, occurs in up to 95% of patients receiving radiation therapy. There is currently no standard therapy for this treatment-related adverse effect. The aim of this study is to investigate the safety and tolerability (Phase I) and preliminary efficacy (Phase II) of prophylactic esomeprazole cream ( termed "Dermaprazole") in patients who require radiation for either breast cancer in the postmastectomy setting or head and neck cancer in the definitive or adjuvant setting.
Conditions:
Radiation Dermatitis Breast Cancer Head and Neck Cancer
Study Start (Actual) 2023-04-24
Primary Completion (Estimated) 2025-01
Study Completion (Estimated) 2027-01
Enrollment (Estimated) 57
Study Type INTERVENTIONAL
Phase PHASE1
Locations:
📍 Houston, Texas, United States
📍 Houston, Texas, United States
📍 Houston, Texas, United States

Eligibility Criteria

Description

    Inclusion Criteria:

    • Arm B: Breast cancer arm
    • 1. Women with breast cancer, treated with ipsilateral i) Simple (total) mastectomy (nipple sparing mastectomy is same as total mastectomy), OR ii) Modified radical mastectomy, OR iii)Radical mastectomy
    • 2. Histological diagnosis of invasive ductal or lobular carcinoma (diagnosed within 2 years of enrollment)
    • 3. Planned to receive adjuvant chest wall radiation of at least 40Gy or higher biologically equivalent dose (BED)
    • 4. Age 18 years or older
    • 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
    • 6. Written Informed Consent
    • 7. History and Physical within 12 weeks of enrollment
    • Arm A: Head \& Neck cancer arm
    • 1. Patients with squamous cell carcinoma of the head and neck confirmed with institutional pathology (diagnosed within 2 years of enrollment)
    • 2. Planned to receive concurrent chemoradiation with any radiosensitizing regimen (such as cisplatin) of at least 60 Gy or higher (note: chemotherapy per medical oncology and otolaryngology).
    • 3. Age 18 years or older
    • 4. ECOG performance status 0 to 2
    • 5. Written Informed Consent
    • 6. History and Physical within 12 weeks of enrollment

    Exclusion Criteria:

    • Arm B: Breast Cancer arm
    • 1. Prior chest wall radiotherapy
    • 2. 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
    • 3. Concurrent chemotherapy
    • 4. Biopsy-proven epidermal involvement or positive margins
    • 5. Open wound at time of consultation, or delayed surgical wound healing as defined as open wound \>8 weeks post-op
    • 6. Known active collagen vascular disease such as systemic lupus erythematous, scleroderma or dermatomyositis.
    • 7. Allergy or sensitivity to proton pump inhibitors
    • 8. Pregnancy or breast feeding
    • 9. Use of clopidrogrel, St. Johns Wort, rifampin, or methotrexate
    • Arm A: Head \& Neck cancer arm
    • 1. Prior head and neck radiotherapy
    • 2. 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
    • 3. Lack of concurrent chemotherapy
    • 4. Open wound at time of simulation
    • 5. Known active collagen vascular diseases such as systemic lupus erythematous, scleroderma or dermatomyositis.
    • 6. Allergy or sensitivity to proton pump inhibitors
    • 7. Pregnancy or breast feeding (pregnancy test prior to CT simulation if the patient is not on a medication that prevents pregnancy)
    • 8. Use of clopidrogrel, St. Johns Wort, rifampin, or methotrexate
Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted2022-02-25
  • First Submitted that Met QC Criteria2022-02-25
  • First Posted2022-03-07

Study Record Updates

  • Last Update Submitted that Met QC Criteria2023-11-13
  • Last Update Posted2023-11-14
  • Last Verified2023-11