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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05190770
• Other study ID #: 21-091
• Status: Recruiting
• Phase: Phase 2
• Start date: December 15, 2021
• Est. completion date: December 15, 2026

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Alina Markova, MD
• Phone: 646-608-2342
• Email: markovaa[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 15, 2026
• Est. primary completion date: December 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Stage
• Breast Cancer Stage I
• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Cancer Stage IV
• Breast Neoplasms
• Dermatitis
• Radiodermatitis

Intervention

Drug:
• Triamcinolone Acetonide
Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (All protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)

External Links

•   Memorial Sloan Kettering Cancer Center