A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in Patients with Breast Cancer
This phase II trial tests whether Oleogel-S10 gel works in treating radiation dermatitis in patients with breast cancer. Oleogel-S10 is made from natural ingredients (birch bark extract and sunflower oil), and it has been shown to fight bacteria, viruses, fungi, and inflammation, and to prevent the development of skin tumors/growths. Adding Oleogel-S10 to standard of care triamcinolone may heal skin wounds caused by radiation dermatitis.
Inclusion Criteria
- Patients who are receiving post-mastectomy radiation therapy (PMRT) to the chest wall or post-lumpectomy radiation therapy (RT) to the whole breast for 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 abstain 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
Additional locations may be listed on ClinicalTrials.gov for NCT05190770.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Middletown
New York
New York
West Harrison
PRIMARY OBJECTIVE:
I. To assess the efficacy of topical Oleogel-S10 gel vs placebo (vehicle gel) when added to standard of care (triamcinolone 0.1% cream) in reducing radiation wound body surface area, when applied for 14 days to the radiated area of skin in patients with breast cancers and grade 2/3 dermatitis.
SECONDARY OBJECTIVES:
I. To assess the efficacy of topical Oleogel-S10 gel vs placebo (vehicle gel) when added to standard of care (triamcinolone 0.1% cream) in reducing radiation wound body surface area, when applied for 21 days to the radiated area of skin in patients with breast cancers and grade 2/3 dermatitis.
II. To determine the effect of topical Oleogel-S10 gel vs placebo (vehicle gel) when added to standard of care (triamcinolone 0.1% cream) on the time to resolution of grade 2/3 radiation dermatitis via standardized photography.
III. To evaluate adverse events (AEs) as determined by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 grading.
IV. To assess health-related quality of life (HRQoL), as assessed by patient reported outcome (PRO)-CTCAE and the Radiation-Induced Skin Reaction Assessment Scale (RISRAS).
EXPLORATORY OBJECTIVES:
I. To characterize time to resolution of acute radiation dermatitis (ARD) in intertriginous versus (vs) non-intertriginous skin and with respect to radiation dose.
II. To characterize late effects of radiation, such as fibrosis, telangiectasias, hyperpigmentation, and dermatitis.
III. To characterize the typical timeline of AE occurrence.
IV. To assess patient compliance with the application of topical Oleogel-S10 gel or placebo.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive standard of care triamcinolone topically in the morning and Oleogel-S10 gel topically in the evening (60 minutes before bedtime) for 21 days.
GROUP II: Patients receive standard of care triamcinolone topically in the morning and placebo gel topically in the evening (60 minutes before bedtime) for 21 days.
After completion of study treatment, patients are followed up for 27 weeks.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorAlina Markova
- Primary ID21-091
- Secondary IDsNCI-2022-00366
- ClinicalTrials.gov IDNCT05190770