Dermaprazole for the Management of Radiation Dermatitis in Head and Neck and Breast Cancer Patients Undergoing Radiation Therapy, TOPAZ Trial

Inclusion Criteria

• ARM B-BREAST CANCER ARM: Women with breast cancer, treated with ipsilateral * Simple (total) mastectomy, OR * Modified radical mastectomy, OR * Radical mastectomy
• ARM B-BREAST CANCER ARM: Histological diagnosis of invasive ductal or lobular carcinoma (diagnosed within 2 years of enrollment)
• ARM B-BREAST CANCER ARM: Planned to receive adjuvant chest wall radiation of at least 40Gy or higher biologically equivalent dose (BED)
• ARM B-BREAST CANCER ARM: Age 18 years or older
• ARM B-BREAST CANCER ARM: Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• ARM B-BREAST CANCER ARM: Written informed consent
• ARM B-BREAST CANCER ARM: History and physical within 12 weeks of enrollment
• ARM A-HEAD AND NECK CANCER ARM: Patients with squamous cell carcinoma of the head and neck confirmed with institutional pathology (diagnosed within 2 years of enrollment)
• ARM A-HEAD AND NECK CANCER ARM: 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)
• ARM A-HEAD AND NECK CANCER ARM: Age 18 years or older
• ARM A-HEAD AND NECK CANCER ARM: ECOG performance status 0 to 2
• ARM A-HEAD AND NECK CANCER ARM: Written informed consent
• ARM A-HEAD AND NECK CANCER ARM: History and physical within 12 weeks of enrollment

Exclusion Criteria

• ARM B-BREAST CANCER ARM: Prior chest wall radiotherapy
• ARM B-BREAST CANCER ARM: 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
• ARM B-BREAST CANCER ARM: Concurrent chemotherapy
• ARM B-BREAST CANCER ARM: Biopsy-proven epidermal involvement or positive margins
• ARM B-BREAST CANCER ARM: Open wound at time of consultation, or delayed surgical wound healing as defined as open wound > 8 weeks post-operative (post-op)
• ARM B-BREAST CANCER ARM: Known active collagen vascular disease such as systemic lupus erythematous, scleroderma or dermatomyositis
• ARM B-BREAST CANCER ARM: Allergy or sensitivity to proton pump inhibitors
• ARM B-BREAST CANCER ARM: Pregnancy or breast feeding
• ARM B-BREAST CANCER ARM: Use of clopidrogrel, St. John’s Wort, rifampin, or methotrexate
• ARM A-HEAD AND NECK CANCER ARM: Prior head and neck radiotherapy
• ARM A-HEAD AND NECK CANCER ARM: 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
• ARM A-HEAD AND NECK CANCER ARM: Lack of concurrent chemotherapy
• ARM A-HEAD AND NECK CANCER ARM: Open wound at time of simulation
• ARM A-HEAD AND NECK CANCER ARM: Known active collagen vascular diseases such as systemic lupus erythematous, scleroderma or dermatomyositis
• ARM A-HEAD AND NECK CANCER ARM: Allergy or sensitivity to proton pump inhibitors
• ARM A-HEAD AND NECK CANCER ARM: Pregnancy or breast feeding
• ARM A-HEAD AND NECK CANCER ARM: Use of clopidrogrel, St. John’s Wort, rifampin, or methotrexate