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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 belowSelect...
Both sides of my neck will receive the same radiation dose for my head and neck cancer.
Select...
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:Select...
I am receiving a specific type of intense radiation therapy for my breast.
Select...
I am thin and need a specific treatment for cancer spread to my lymph nodes.
Select...
I've had radiation near the area to be treated before.
Select...
I have an active infection at the expected treatment area.
Select...
I have skin grafts on the area that needs treatment.
Select...
I am currently taking capecitabine.
Select...
I need help with my daily activities due to my health condition.
Select...
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
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.
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.
Find a Location
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
236 Previous Clinical Trials
2,089,580 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
1,006 Previous Clinical Trials
7,413,919 Total Patients Enrolled
Kiri A Cook, MDPrincipal InvestigatorOHSU Knight Cancer Institute
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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