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

Primary Purpose

Breast Cancer, Breast Cancer Stage, Breast Cancer Stage I

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Triamcinolone Acetonide
Oleogel-S10
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Radiation Dermatitis, PMRT, Breast cancer, Oleogel-S10, Triamcinolone acetonide, Memorial Sloan Kettering Cancer Center, 21-091

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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

Sites / Locations

  • Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (All protocol activities)Recruiting
  • Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Triamcinolone + Oleogel-S10

Triamcinolone + Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 29, 2021
Last Updated
August 22, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05190770
Brief Title
A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 15, 2026 (Anticipated)
Study Completion Date
December 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Cancer Stage, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Stage IV
Keywords
Radiation Dermatitis, PMRT, Breast cancer, Oleogel-S10, Triamcinolone acetonide, Memorial Sloan Kettering Cancer Center, 21-091

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Triamcinolone + Oleogel-S10
Arm Type
Experimental
Arm Description
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.
Arm Title
Triamcinolone + Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.
Intervention Type
Drug
Intervention Name(s)
Oleogel-S10
Intervention Description
Oleogel-S10 consists of birch bark extract (TE): 10 mg/100 mg; Sunflower oil, refined: 90 mg/100 mg. It is applied topically.
Primary Outcome Measure Information:
Title
Reduction of radiation dermatitis grade 2-3 wound size from baseline to day 14 (+/- 3 days)
Description
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.
Time Frame
14 days from baseline (+/- 3 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alina Markova, MD
Phone
646-608-2342
Email
markovaa@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Lacouture, MD
Phone
646-608-2337
Email
LacoutuM@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alina Markova, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina Markova, MD
Phone
646-608-2342
Facility Name
Memorial Sloan Kettering Monmouth (All protocol activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina Markova, MD
Phone
646-608-2342
Facility Name
Memorial Sloan Kettering Westchester (All Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina Markova, MD
Phone
646-608-2342
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina Markova, MD
Phone
646-608-2342

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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