Topical Dermaprazole for Radiation Dermatitis in Breast Cancer and Head and Neck Cancer Patients (TOPAZ)
Radiation Dermatitis, Breast Cancer, Head and Neck Cancer
About this trial
This is an interventional supportive care trial for Radiation Dermatitis focused on measuring Radiation dermatitis, post-mastectomy, radiation therapy, breast cancer, head and neck cancer
Eligibility Criteria
Inclusion Criteria:
Arm B: Breast cancer arm
- Women with breast cancer, treated with ipsilateral i) Simple (total) mastectomy, OR ii) Modified radical mastectomy, OR iii)Radical mastectomy
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- 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 of enrollment)
- 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).
- Age 18 years or older
- ECOG performance status 0 to 2
- Written Informed Consent
- History and Physical within 12 weeks of enrollment
Exclusion Criteria:
Arm B: Breast Cancer arm
- Prior chest wall radiotherapy
- 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
- Concurrent chemotherapy
- Biopsy-proven epidermal involvement or positive margins
- Open wound at time of consultation, or delayed surgical wound healing as defined as open wound >8 weeks post-op
- Known active collagen vascular disease such as systemic lupus erythematous, scleroderma or dermatomyositis.
- Allergy or sensitivity to proton pump inhibitors
- Pregnancy or breast feeding
- Use of clopidrogrel, St. Johns Wort, rifampin, or methotrexate
Arm A: Head & Neck cancer arm
- Prior head and neck radiotherapy
- 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
- Lack of concurrent chemotherapy
- Open wound at time of simulation
- Known active collagen vascular diseases such as systemic lupus erythematous, scleroderma or dermatomyositis.
- Allergy or sensitivity to proton pump inhibitors
- Pregnancy or breast feeding
- Use of clopidrogrel, St. Johns Wort, rifampin, or methotrexate
Sites / Locations
- Baylor College of Medicine Medical Center - McNair CampusRecruiting
- Baylor St. Luke's Medical CenterRecruiting
- Harris Health System - Smith ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Dermaprazole 1% (Arm A:Head and neck)
Dermaprazole 1% (ArmB: Breast)
Dermaprazole 2% (Arm A: Head and neck)
Dermaprazole 2% (Arm B: Breast)
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.