What side effects are associated with this type of intervention?

Common treatments for radiation dermatitis include topical corticosteroids, emollients, and protective barriers like StrataXRT. Topical corticosteroids can cause skin thinning, irritation, and potential systemic absorption leading to hormonal side effects if used extensively. Emollients are generally well-tolerated but can sometimes cause mild skin irritation or allergic reactions. Protective barriers, such as StrataXRT, aim to reduce skin irritation and promote healing with minimal side effects, though some patients may experience mild skin reactions or discomfort at the application site.

What prior FDA approvals exist?

FDA-approved treatments for radiation dermatitis often include topical agents designed to protect the skin and promote healing. These treatments typically involve the use of corticosteroid creams, emollients, and barrier films. For example, products like Aquaphor and Biafine have been used to manage radiation-induced skin reactions by providing a protective barrier and moisturizing the skin. While specific FDA approvals for barrier treatments like StrataXRT are not detailed, the general approach involves using topical formulations to mitigate skin irritation and support the healing process.

What other types of research exist?

Promising novel alternatives to StrataXRT for radiation dermatitis include: 1) Topical corticosteroids, which are commonly used to reduce inflammation and irritation. 2) Topical calcipotriol combined with high-potency corticosteroids, which have shown efficacy in managing skin conditions. 3) Daylight photodynamic therapy, which has been effective and nearly painless for treating skin conditions like actinic keratosis and may have potential for radiation dermatitis. 4) Zinc gluconate, which has shown benefits in improving skin conditions and may help in reducing skin irritation and promoting healing.

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Silicone-based Gel for Radiation Dermatitis in Breast and Head & Neck Cancers

N/A

Waitlist Available

Led By Kiri A Cook, MD

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All head and neck cancer patients should have the left and right neck treated to the same dose when receiving bilateral neck irradiation

Histologically confirmed malignancy for which standard curative measures in conjunction with radiotherapy are indicated to the following sites: whole breast/chest-wall for post-surgical radiotherapy or bilateral neck (levels one through six) for head and neck cancer

Must not have

Patients receiving ultra-hypofractionated radiation to the breast

Thin patients with nodal involvement requiring bolus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 6 +/- 1 post-rt

Awards & highlights

No Placebo-Only Group

Summary

This trial studies whether StrataXRT gel can prevent and treat skin damage in breast cancer or head and neck cancer patients receiving radiation therapy. The gel forms a protective film on the skin, helping to reduce irritation and promote healing. StrataXRT® is a silicone-based gel that has been shown to be effective in preventing and delaying skin damage in patients undergoing radiotherapy.

Who is the study for?

This trial is for adults with breast or head and neck cancers who need radiotherapy. It's open to all genders, races, and ethnic groups. Participants must be able to apply StrataXRT themselves and sign a consent form. Excluded are those with concurrent capecitabine treatment, skin grafts at the site, poor performance status (ECOG >=3), prior radiation in the area, significant hair obstructing application, active infections at the site, pregnant women or decisionally impaired.

What is being tested?

The study tests if StrataXRT can prevent or treat radiation dermatitis—a common side effect of radiotherapy causing severe skin irritation—in patients undergoing treatment for breast cancer or head and neck cancers. The effectiveness of various topical treatments like hydrocortisone and silicone-based gels will be compared.

What are the potential side effects?

Potential side effects may include local skin reactions such as redness, itching or burning sensation where StrataXRT is applied. There might also be allergic reactions to any of the gel's components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Both sides of my neck will receive the same radiation dose for my head and neck cancer.

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My cancer diagnosis is confirmed and requires standard treatment with radiotherapy to my breast/chest or neck.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am receiving a specific type of intense radiation therapy for my breast.

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I am thin and need a specific treatment for cancer spread to my lymph nodes.

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I've had radiation near the area to be treated before.

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I have an active infection at the expected treatment area.

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I have skin grafts on the area that needs treatment.

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I am currently taking capecitabine.

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I need help with my daily activities due to my health condition.

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My cancer is visible on my skin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 6 +/- 1 post-rt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 6 +/- 1 post-rt

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 6 +/- 1 post-rt for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Radiation dermatitis

Secondary study objectives

Grade 2+ radiation dermatitis

Post-RT recovery time (to grade =< 1 radiation dermatitis

Weekly Common Terminology Criteria for Adverse Events (CTCAE) scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (StrataXRT)Experimental Treatment1 Intervention

Patients apply StrataXRT topically to the affected area once or twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =\< 1.

Group II: Arm II (standard of care)Active Control5 Interventions

Patients receive standard of care including calendula and/or Aquaphor applied 2-6 times daily plus hydrogel or Silvadene or topical corticosteroids applied twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =\< 1.

0 / 10Eligibility 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

Common treatments for radiation dermatitis include topical corticosteroids, emollients, and protective barrier films like StrataXRT. Topical corticosteroids reduce inflammation and immune response, helping to alleviate redness and swelling. Emollients moisturize and soothe the skin, preventing dryness and cracking. Protective barrier films, such as StrataXRT, form a physical shield over the skin, reducing friction and exposure to irritants while promoting a moist environment conducive to healing. These mechanisms are crucial for radiation dermatitis patients as they help manage symptoms, prevent further skin damage, and promote faster recovery, thereby improving the patient's ability to continue with their radiation therapy.