A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Triamcinolone + Oleogel-S10 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
Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.
Drug: Oleogel-S10
Oleogel-S10 consists of birch bark extract (TE): 10 mg/100 mg; Sunflower oil, refined: 90 mg/100 mg. It is applied topically.
|
| Placebo Comparator: Triamcinolone + Placebo 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
Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.
|
Outcome Measures
Primary Outcome Measures
- Reduction of radiation dermatitis grade 2-3 wound size from baseline to day 14 (+/- 3 days) [14 days from baseline (+/- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who are receiving PMRT to the chest wall for breast cancer of any stage
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Age ≥ 18 years
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Patients who develop ARD grade 2/3 between fraction day 20 - 25 of radiation therapy with all locations of desquamation
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Able to self-administer topical interventions or provide for another person to apply the topical intervention
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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
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Patients have completed surgery or chemotherapy ≥ 4 weeks prior to start of radiation therapy
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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.
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WCBP must agree to abstrain from sex or use a highly effective method of birth control* from the time of consent through visit 5.
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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:
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Patients who are receiving radiation therapy for inflammatory breast cancer or malignant fungating wound
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Known history of allergy to any ingredient of the study medication
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Patients with collagen-vascular disease/vasculitis
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Patients who have been started on or anticipate starting hormonal antagonists during the duration of their radiation therapy
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Patients receiving hypofractionated radiation therapy
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Special populations:
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patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering at Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
| 2 | Memorial Sloan Kettering Westchester | Harrison | New York | United States | 10604 |
| 3 | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Alina Markova, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-091