What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as radiation therapy, chemotherapy, and endocrine therapy, have various side effects. Radiation therapy can cause skin irritation, redness, and radiation dermatitis, which is the focus of the Oleogel-S10 trial. Chemotherapy often leads to alopecia (hair loss), nausea, fatigue, and increased risk of infections. Endocrine therapies, like tamoxifen and aromatase inhibitors, can cause hot flashes, night sweats, and an increased risk of osteoporosis. These treatments aim to manage cancer but come with a range of side effects that can impact the patient's quality of life.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer include a variety of drugs such as hormone therapies (e.g., tamoxifen, letrozole), chemotherapy agents (e.g., doxorubicin, paclitaxel), targeted therapies (e.g., trastuzumab, pertuzumab), and immunotherapies (e.g., pembrolizumab). While specific drugs promoting faster wound healing like Oleogel-S10 are not detailed, corticosteroids like triamcinolone are commonly used to manage skin-related side effects of cancer treatments.

What other types of research exist?

A promising novel alternative to Oleogel-S10 for promoting faster wound healing in breast cancer patients is the use of electrospun scaffolds loaded with ASC-J9. These scaffolds have demonstrated potential in accelerating wound healing by promoting cell proliferation and migration over an extended period.

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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 below

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I am receiving radiation therapy for breast cancer after surgery.

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I can apply medicine to my skin myself or have someone who can do it for me.

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I developed moderate to severe skin reactions during days 20-25 of my radiation therapy.

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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.

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days from baseline (+/- 3 days) for reporting.

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 • NCT03068780

61%

Wound complication

Pyrexia

Pruritus

Wound infection

Anaemia

Wound infection staphylococcal

Wound infection bacterial

Nasopharyngitis

Cough

Diarrhoea

Influenza

Dysphagia

Squamous cell carcinoma skin

Sepsis

Wound haemorrhage

Device related infection

Haematuria

Pneumonia

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

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.