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KeraStat Cream for Radiation Dermatitis in Head and Neck Cancer

N/A

Waitlist Available

Led By Ryan T Hughes, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

Histological or cytological diagnosis of head and neck cancer planned to receive conventionally fractionated radiation therapy targeting the head and neck to a total prescribed dose of at least 60 Gy, including a part of the unilateral and/or bilateral lymph node regions

Be older than 18 years old

Must not have

Early stage squamous cell carcinoma of the glottic larynx planned for treatment with limited field radiation therapy alone

Previous radiation therapy to the area in the head and neck to be treated with radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks after completion of radiation therapy, up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a mobile app called MyCap can effectively gather information about skin rashes from head and neck cancer patients undergoing radiation therapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of KeraStat cream aren't listed here, similar topical treatments may cause skin irritation or allergic reactions at the site of application.

Eligibility Criteria

Inclusion Criteria

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

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I have head and neck cancer and will receive radiation therapy of at least 60 Gy, including lymph node areas.

Exclusion Criteria

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

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

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

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I have scleroderma or lupus and need medication for it.

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My treatment is focused only on the main cancer site, not the lymph nodes.

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I am currently using topical corticosteroids in the area being treated with radiation.

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I am scheduled for a treatment targeting EGFR for my head and neck cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, weekly during radiation therapy, weekly for 4 weeks post radiation therapy, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, weekly during radiation therapy, weekly for 4 weeks post radiation therapy, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, weekly during radiation therapy, weekly for 4 weeks post radiation therapy, up to 2 years for reporting.