Can a simple cream stop radiation burns? early trial halted
NCT ID NCT05269160
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a cream called dermaprazole (a form of esomeprazole) to see if it could prevent or reduce skin burns caused by radiation therapy in women who had mastectomy for breast cancer. Only 3 women were enrolled before the trial was stopped early. The goal was to check safety and whether the cream might help, but the small size and early termination mean no firm conclusions can be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dermaprazole cream (esomeprazole cream)
- What this could lead to
- If it works, this could point toward a simple cream to prevent or reduce painful skin burns from radiation therapy in breast cancer patients.
- What could go wrong
- This was a very small, early-phase trial that was terminated early with only 3 participants, so results are limited and may not apply broadly. The cream's effectiveness and safety are not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
3 people
The number who actually took part.
- Started
-
Apr 2023
- Finished
-
Apr 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 100 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Baylor St. Luke's Medical Center
Houston, Texas, 77054, United States
-
Harris Health System - Smith Clinic
Houston, Texas, 77054, United States
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Other studies related to the condition(s) this trial covers.
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