Status:
RECRUITING
Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ)
Lead Sponsor:
Michelle S Ludwig
Conditions:
Radiation Dermatitis
Breast Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
Brief Summary
Radiotherapy is a mainstay of treatment in breast cancer treatment, in the adjuvant setting. Radiation dermatitis occurs in up to 65% of these patients; currently, there is no standard of care for thi...
Detailed Description
All study participants will begin using Dermaprazole for 1-2 weeks prior to receiving radiation. During the CT Simulation, study participants will be instructed to apply Dermaprazole in a "patch test"...
Eligibility Criteria
Inclusion
- Women with breast cancer, treated with ipsilateral i) Simple (total) mastectomy, OR ii) Modified radical mastectomy, OR iii)Radical mastectomy, OR iv) Segmental mastectomy, OR v) Skin sparing/nipple sparing 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
- Women of childbearing potential (any woman with menses in the last 12 months) must agree to pregnancy testing and contraceptive use throughout the study period. Testing consists of human chorionic gonadotropin (HCG) urine testing, which if suspected to be falsely positive may be confirmed by ultrasound. If ultrasound is negative, patient is considered not pregnant and eligible for inclusion in the study. In addition to routine contraception method such as barrier devices, hormonal methods, and intrauterine devices, heterosexual celibacy, and surgical sterility (hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or a partner with history of vasectomy) is considered acceptable. If a celibate patient chooses to become sexually active during the study period, she must use one of the listed methods of contraception throughout the study period.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Written Informed Consent
- History and Physical within 12 weeks of enrollment
Exclusion
- 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
Key Trial Info
Start Date :
April 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT05269160
Start Date
April 24 2023
End Date
January 1 2028
Last Update
March 12 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor College of Medicine Medical Center - McNair Campus
Houston, Texas, United States, 77030
2
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
3
Harris Health System - Smith Clinic
Houston, Texas, United States, 77054