Using Dermaprazole cream to prevent skin issues in breast cancer patients undergoing radiation
A Phase I/II Study of Dermaprazole for Radiation Dermatitis in Post-Mastectomy Breast Cancer Patients.
This study is testing a cream called Dermaprazole to see if it can help prevent skin problems in women with breast cancer who are about to start radiation therapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Drugs / interventions | chemotherapy, radiation, methotrexate |
| Locations | 3 sites (Houston, Texas and 2 other locations) |
| Trial ID | NCT05269160 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and tolerability of a topical cream called Dermaprazole in women with breast cancer who are receiving radiation therapy. Participants will apply the cream for 1-2 weeks prior to radiation treatment to assess any immediate skin reactions. The study will evaluate two different concentrations of Dermaprazole (1% and 2%) to determine the most effective dose while monitoring for any allergic reactions or skin irritations. The goal is to find a potential preventive treatment for radiation dermatitis, a common side effect of breast cancer radiation therapy.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a recent diagnosis of invasive ductal or lobular carcinoma who are scheduled to receive adjuvant radiation therapy after mastectomy.
Not a fit: Patients who have not undergone mastectomy or those who are not receiving radiation therapy for breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of radiation dermatitis in breast cancer patients, improving their quality of life during and after treatment.
How similar studies have performed: While there is limited data on the specific use of Dermaprazole for this purpose, similar approaches using topical treatments for radiation dermatitis have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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 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. 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. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 7. Written Informed Consent 8. History and Physical within 12 weeks of enrollment Exclusion Criteria: 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
Where this trial is running
Houston, Texas and 2 other locations
- Baylor College of Medicine Medical Center - McNair Campus — Houston, Texas, United States (Recruiting)
- Baylor St. Luke's Medical Center — Houston, Texas, United States (Recruiting)
- Harris Health System - Smith Clinic — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Michelle S Ludwig, MD, MPH, PhD — Baylor College of Medicine
- Study coordinator: Michelle S Ludwig, MD, MPH, PhD
- Email: Michelle.Ludwig@bcm.edu
- Phone: 713-566-3757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.