Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ) (NCT05269160) | Clinical Trial Compass
TerminatedPhase 1/2
Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ)
Stopped: PI is leaving institution and this protocol will not be further pursued at this institution.
United States3 participantsStarted 2023-04-24
Plain-language 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 this treatment-related toxicity. 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 breast cancer in the adjuvant setting.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. 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
What they're measuring
1
Number of Participants With Dose-Limiting Toxicity(DLT) in Phase I
Timeframe: from the first day applying the Dermaprazole cream until 1 month after the subject has completed their last radiation treatment, up to 13 weeks
2
Rate of Clinically Bothersome Radiation Dermatitis at Maximum Feasible Dose in Phase II
Timeframe: at weekly during radiation treatment, up to 7 weeks
✓. History and Physical within 12 weeks of enrollment
Exclusion criteria
✕. 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