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

Q: What is the capacity of participants for this clinical investigation?

This clinical trial has concluded its recruitment process, with the original posting being on December 1st 2022 and last update occurring on November 9th 2022. If one is seeking alternative studies, there are presently 4798 trials recruiting patients suffering from radiation-induced dermatitis and 3 more for those trying out Silicone-based Film Forming Topical Gel.

Q: Are there any analogous experiments involving Silicone-based Film Forming Topical Gel?

Currently, 3 clinical trials for Silicone-based Film Forming Topical Gel are ongoing and none have reached Phase 3. Of the 7 locations running these medical experiments, most of them reside in Pittsburgh, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>.

Q: Are there still open spots in this clinical trial?

This research project is not presently enrolling participants. The trial was first listed on December 1st 2022 and its last update occurred on November 9th 2022. For those interested in similar studies, there are 4798 trials actively searching for individuals with radiation-induced dermatitis as well as 3 investigations related to Silicone-based Film Forming Topical Gel that require patients to participate.

Q: What therapeutic conditions does Silicone-based Film Forming Topical Gel address?

Severe wounds, third-degree burns, and septicemia can be addressed using Silicone-based Film Forming Topical Gel.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until healed (grade =< 1 dermatitis), up to 10 weeks

Awards & highlights

Study Summary

This trial is studying StrataXRT to see if it can help prevent skin damage from radiation therapy.

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.Check my eligibility

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.See study design

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

Select...

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until healed (grade =< 1 dermatitis), up to 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until healed (grade =< 1 dermatitis), up to 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and until healed (grade =< 1 dermatitis), up to 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Radiation dermatitis

Secondary outcome measures

Grade 2+ radiation dermatitis

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

Time to peak Common Terminology Criteria for Adverse Events (CTCAE) score

+1 more

Other outcome measures

Average cost of StrataXRT tubes

Incidence of use of skin care products in addition to StrataXRT

Number of days missed (attributable to patient or provider concern re: dermatologic toxicity)

+2 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor

230 Previous Clinical Trials

2,090,634 Total Patients Enrolled

Oregon Health and Science UniversityOTHER

973 Previous Clinical Trials

6,845,937 Total Patients Enrolled

Kiri A Cook, MDPrincipal InvestigatorOHSU Knight Cancer Institute

Media Library

Radiation Dermatitis Clinical Trial 2023: StrataXRT Highlights & Side Effects. Trial Name: NCT05073172 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of participants for this clinical investigation?

"This clinical trial has concluded its recruitment process, with the original posting being on December 1st 2022 and last update occurring on November 9th 2022. If one is seeking alternative studies, there are presently 4798 trials recruiting patients suffering from radiation-induced dermatitis and 3 more for those trying out Silicone-based Film Forming Topical Gel."

Answered by AI

Are there any analogous experiments involving Silicone-based Film Forming Topical Gel?

"Currently, 3 clinical trials for Silicone-based Film Forming Topical Gel are ongoing and none have reached Phase 3. Of the 7 locations running these medical experiments, most of them reside in Pittsburgh, Pennsylvania."

Answered by AI

Are there still open spots in this clinical trial?

"This research project is not presently enrolling participants. The trial was first listed on December 1st 2022 and its last update occurred on November 9th 2022. For those interested in similar studies, there are 4798 trials actively searching for individuals with radiation-induced dermatitis as well as 3 investigations related to Silicone-based Film Forming Topical Gel that require patients to participate."

Answered by AI