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Oleogel-S10 + Standard Cream for Radiation Dermatitis
Phase 2
Waitlist Available
Led By Alina Markova, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who are receiving PMRT to the chest wall or post-lumpectomy RT to the whole breast cancer of any stage
Able to self-administer topical interventions or provide for another person to apply the topical intervention
Must not have
Patients who are receiving radiation therapy for inflammatory breast cancer or malignant fungating wound
Patients receiving hypofractionated radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days from baseline (+/- 3 days)
Summary
This trial is testing if a new gel (Oleogel-S10) combined with a common skin cream (triamcinolone) can help patients with radiation dermatitis heal faster. The gel speeds up healing, and the cream reduces irritation and inflammation. Triamcinolone has been used for over 50 years as a first-line therapy for many inflammatory skin disorders.
Who is the study for?
This trial is for adults over 18 with any stage of breast cancer who are undergoing radiation therapy and have developed moderate to severe skin irritation (grade 2/3) during treatment. They must not be using other topical treatments, have finished surgery or chemotherapy at least four weeks prior, and if they can become pregnant, agree to effective birth control.
What is being tested?
The study tests Oleogel-S10 gel combined with triamcinolone cream against radiation dermatitis in breast cancer patients. Oleogel-S10 may speed up healing of skin wounds like burns, while triamcinolone treats various severe skin conditions.
What are the potential side effects?
Possible side effects include allergic reactions to ingredients in the medications, increased risk of infection due to open skin wounds from dermatitis, and typical steroid-related effects such as thinning of the skin or changes in pigmentation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am receiving radiation therapy for breast cancer after surgery.
Select...
I can apply medicine to my skin myself or have someone who can do it for me.
Select...
I developed moderate to severe skin reactions during days 20-25 of my radiation therapy.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am undergoing radiation for inflammatory breast cancer or a cancerous open sore.
Select...
I am receiving a type of radiation therapy with fewer, larger doses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days from baseline (+/- 3 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days from baseline (+/- 3 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Reduction of radiation dermatitis grade 2-3 wound size from baseline to day 14 (+/- 3 days)
Side effects data
From 2022 Phase 3 trial • 223 Patients • NCT0306878061%
Wound complication
8%
Pyrexia
7%
Pruritus
7%
Wound infection
7%
Anaemia
4%
Wound infection staphylococcal
3%
Wound infection bacterial
3%
Nasopharyngitis
3%
Cough
2%
Diarrhoea
2%
Influenza
2%
Dysphagia
1%
Sepsis
1%
Wound haemorrhage
1%
Squamous cell carcinoma skin
1%
Device related infection
1%
Haematuria
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oleogel-S10 (DBP)
Control Gel (DBP)
Former Oleogel-S10 (OLP)
Former Control Gel (OLP)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Triamcinolone + Oleogel-S10Experimental Treatment2 Interventions
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.
Group II: Triamcinolone + PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triamcinolone Acetonide
2018
Completed Phase 4
~3730
Oleogel-S10
2010
Completed Phase 3
~280
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Breast cancer treatments often involve a combination of therapies to target cancer cells and manage side effects. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects.
Hormone therapy, such as tamoxifen, blocks hormones like estrogen that can promote cancer growth in hormone receptor-positive breast cancer. Targeted therapies, like trastuzumab, specifically target cancer cell proteins (e.g., HER2) to inhibit tumor growth.
In the context of radiation dermatitis, treatments like Oleogel-S10 combined with triamcinolone aim to promote faster wound healing and reduce inflammation, which is crucial for improving the quality of life for breast cancer patients undergoing radiation therapy.
Estrogen induces CXCR4 overexpression and CXCR4/CXL12 pathway activation in lung adenocarcinoma cells in vitro.
Estrogen induces CXCR4 overexpression and CXCR4/CXL12 pathway activation in lung adenocarcinoma cells in vitro.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,963 Previous Clinical Trials
597,378 Total Patients Enrolled
206 Trials studying Breast Cancer
83,981 Patients Enrolled for Breast Cancer
Alina Markova, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
798 Total Patients Enrolled
1 Trials studying Breast Cancer
1 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving radiation therapy for breast cancer after surgery.I can stop using other skin treatments once I join the study.I am undergoing radiation for inflammatory breast cancer or a cancerous open sore.I can apply medicine to my skin myself or have someone who can do it for me.I developed moderate to severe skin reactions during days 20-25 of my radiation therapy.I am using a highly effective form of birth control or am not of childbearing potential.I finished surgery or chemotherapy more than 4 weeks ago.You have a collagen-vascular disease or vasculitis.I am 18 years old or older.I am receiving a type of radiation therapy with fewer, larger doses.
Research Study Groups:
This trial has the following groups:- Group 1: Triamcinolone + Placebo
- Group 2: Triamcinolone + Oleogel-S10
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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