A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is find out whether Oleogel-S10 is an effective treatment for radiation dermatitis when it is used in combination with a standard wound treatment cream called triamcinolone. Oleogel-S10 has shortened the healing time for other types of skin wounds such as burns. Triamcinolone is a cream that is frequently used to treat moderate to severe skin conditions such as skin irritation caused by poison ivy, eczema, sunburn, and rashes.

Official Title
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A Randomized Phase II Double-Blinded Study of The Efficacy of Oleogel-S10 (AP101) Gel for the Treatment of Grade 2/3 Radiation Dermatitis in Breast Cancer Patients

Conditions
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Breast Cancer, Breast Cancer Stage, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Stage IV

Intervention / Treatment
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* Drug: Triamcinolone Acetonide
* Drug: Oleogel-S10


Participation Criteria
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Eligibility Criteria
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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 between fraction day 20 - 25 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triamcinolone + Oleogel-S10<br>25 participants will be randomized to triamcinolone 0.1% cream once every morning and topical Oleogel-S10 gel once prior to bedtime for a 3 week period. | Drug: Triamcinolone Acetonide<br>* Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.<br>Drug: Oleogel-S10<br>* Oleogel-S10 consists of birch bark extract (TE): 10 mg/100 mg; Sunflower oil, refined: 90 mg/100 mg. It is applied topically.<br>|
| Placebo Comparator: Triamcinolone + Placebo<br>25 patients with breast cancer will be randomized to triamcinolone 0.1% cream once every morning (QAM) and vehicle gel once prior to bedtime for a 3 week period. | Drug: Triamcinolone Acetonide<br>* Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of radiation dermatitis grade 2-3 wound size from baseline to day 14 (+/- 3 days) | The primary outcome of this study is the efficacy of Oleogel-S10 in reducing radiation dermatitis grade 2-3 wound size in patient with breast cancer undergoing external beam radiation therapy. Clinical assessment at all study visits, including wound surface area and adverse events will be performed by a dermatologist. Wound size will be measured using a HIPAA compliant 3D clinical imaging system. | 14 days from baseline (+/- 3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation Dermatitis, PMRT, Breast cancer, Oleogel-S10, Triamcinolone acetonide, Memorial Sloan Kettering Cancer Center, 21-091