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

March 4, 2024 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
        • Contact:
          • Alina Markova, MD
          • Phone Number: 646-608-2342
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All Protocol Activities)
        • Contact:
          • Alina Markova, MD
          • Phone Number: 646-608-2342
    • New York
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (All Protocol Activities)
        • Contact:
          • Alina Markova, MD
          • Phone Number: 646-608-2342
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Alina Markova, MD
          • Phone Number: 646-608-2342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)
Time Frame: 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.
14 days from baseline (+/- 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Alina Markova, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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