KeraStat Cream for Radiation Dermatitis in Head and Neck Cancer

Overseen By Principal Investigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Topical corticosteroids, Anti-EGFR biologics

Disqualifiers: Early stage cancer, Previous radiation, Scleroderma, Lupus, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

16 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to test the ability of a mobile device application (MyCap) to collect patient information about their radiation skin rash in patients with head and neck cancer being treated with radiation therapy.

Research Team

Ryan Hughes, M.D.

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals with head and neck cancers who are undergoing radiation therapy and experiencing radiation dermatitis, a type of skin rash. Participants should be willing to use the MyCap app to report on their condition.

Inclusion Criteria

Ability to understand and the willingness to sign an IRB-approved informed consent document in English

Able and willing to complete electronic toxicity and quality of life assessments in the MyCap application using their personal mobile device

I have a clinical diagnosis of head and neck cancer without a confirmed pathology.

Exclusion Criteria

I have early-stage vocal cord cancer and will be treated with targeted radiation only.

I have had radiation therapy on my head or neck before.

I have scleroderma or lupus and need medication for it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive radiation therapy for head and neck cancer while using KeraStat cream to assess radiation dermatitis

Up to 2 years

Weekly visits during radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after radiation therapy, including weekly assessments for 4 weeks post-therapy

4 weeks

Weekly visits for 4 weeks post radiation therapy

Patient Engagement and Satisfaction Assessment

Participants engage with the MyCap app for data collection and provide feedback on satisfaction with the M-PART framework

4 weeks after completion of radiation therapy

Treatment Details

Interventions

• KeraStat Cream

Trial Overview The study tests KeraStat cream's effectiveness in treating acute radiation dermatitis. It involves clinical assessments, using the cream, reporting symptoms via MyCap app, and providing feedback through a phone interview.

Participant Groups

Group I: M-PART Assessment via MyCap Experimental Treatment 4 Interventions

Assessment through the MyCap app to assess radiation dermatitis with the use of Kerastat cream.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+