Birch bark gel shows promise for healing radiation burns in breast cancer
NCT ID NCT05190770
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a gel made from birch bark extract (Oleogel-S10) can help heal skin burns caused by radiation therapy in breast cancer patients. 18 women with moderate to severe radiation dermatitis used the gel along with a standard steroid cream. The goal was to see if the wound size shrank more quickly than with standard care alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Oleogel-S10 (birch bark extract gel) and triamcinolone acetonide cream
- What this could lead to
- If it works, this could offer a new way to heal skin burns from radiation therapy faster and more comfortably for breast cancer patients.
- What could go wrong
- This is a very small, early-phase trial with only 18 participants, so results may not apply to everyone. The gel may not work better than standard care, and skin irritation is possible.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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18 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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Aug 2024
- Lead sponsor
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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 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Patients who are receiving PMRT to the chest wall or post-lumpectomy RT to the whole breast cancer of any stage * Age ≥ 18 years * Patients who develop ARD grade 2/3 after fraction day 20 (when receiving 25 total fractions) or after fraction day 25 when receiving (30 total fraction inclusive of a 5 fraction boost) of radiation therapy with all locations of desquamation * Able to self-administer topical interventions or provide for another person to apply the topical intervention * Patients may be started on any topicals prior to study enrollment. Once patient is enrolled on study (on or before Day 1), patient must be able to discontinue other topicals (including topical steroids, Silvadene, calcineurin inhibitors) to the treatment area * Patients have completed surgery or chemotherapy ≥ 4 weeks prior to start of radiation therapy. Patients may receive antibody-drug conjugates at any time before/during/after study * Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 0) and documented monthly. * WCBP must agree to abstrain from sex or use a highly effective method of birth control\* from the time of consent through visit 5. * Adequate contraceptive methods include those with a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as abstinence from sexual intercourse, and some double barrier methods (condom with spermicide) in conjunction with use by the partner of an intrauterine device, diaphragm with spermicide, oral contraceptives, birth control patch or vaginal ring, or injectable or implanted contraceptives. Abstinence is acceptable only as true abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. A woman that is postmenopausal (≥2 years since last menstrual period) or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) is not considered a WCBP. Exclusion Criteria: * Patients who are receiving radiation therapy for inflammatory breast cancer or malignant fungating wound * Known history of allergy to any ingredient of the study medication * Patients with collagen-vascular disease/vasculitis * Patients receiving hypofractionated radiation therapy * Special populations: * patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent
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Genom att skicka in godkänner du våra Användarvillkor
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
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
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Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
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