M-PART in Head and Neck Cancer Patients Treated With KeraStat Cream for Acute Radiation Dermatitis

Completed · Not applicable

Conditions studied: Radiation Dermatitis

In brief

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.

Key facts

Study ID

NCT06441266

Run by

Wake Forest University Health Sciences

People needed

16

Starts

2025-05-08

Expected to finish

2026-06-08

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological or cytological diagnosis of head and neck cancer (of any part of the oral cavity, pharynx, larynx, or sinuses) planned to receive conventionally fractionated radiation therapy (RT) targeting the head and neck to a total prescribed dose of at least 50 Gy. The 50 Gy radiation therapy target must include at least a part of the unilateral and/or bilateral lymph node regions of the head/neck. Planned prescribed dose will be reviewed and approved by the study principal investigator.
• NOTE: Patients without a clear pathologic diagnosis of invasive disease (i.e., biopsy showing at least carcinoma in situ) but with clinically diagnosed head and neck cancer planned for treatment as above are also eligible.
• Age ≥ 18 years at the time of enrollment.
• Able and willing to complete electronic toxicity and quality of life assessments in the MyCap application using their personal mobile device.
• Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative) in English.

You may not qualify if…

• Early stage (Stage I-II) squamous cell carcinoma of the glottic larynx planned for treatment with limited field radiation therapy alone. These participants are excluded since they are expected to receive a more limited exposure to radiation therapy.
• Patients planned for treatment to the primary site alone without regional lymph node targeting.
• Previous radiation therapy to the area in the head and neck to be treated with radiation therapy.
• Active use of topical corticosteroids in the irradiation area at the time of enrollment. Note that it is acceptable to use topical corticosteroids if study participants develop moist desquamation during radiation therapy.
• History of scleroderma or active lupus requiring systemic medication at the time of enrollment.
• Planned concurrent treatment with anti-EGFR biologic therapy (e.g., cetuximab) for head and neck cancer.
• Individuals who are pregnant or plan to become pregnant. Radiotherapy is contraindicated in this patient population.

Where it is running

• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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