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

Pilot Study of Multi-platform Assessment of Radiation Toxicity (M-PART) in Head and Neck Cancer Patients Treated With KeraStat® Cream for Acute Radiation Dermatitis

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.

Primary Objective: To determine the feasibility of M-PART for the assessment of acute radiation dermatitis in patients treated with radiotherapy for head and neck cancer via MyCap.

Secondary Objectives:

• To assess agreement between site clinician-rated CTCAE G2+ radiation dermatitis with moist desquamation and patient-reported moist desquamation (a and b above).
• To assess the proportion of patient-submitted photographs of skin in the irradiated area that are evaluable for radiation dermatitis assessments by central review.
• To assess agreement between clinician-rated radiation dermatitis grading, central review of patient-submitted photographs, and central review of standardized clinic photographs (methods a, c, and d above).
• To measure the level of interval (i.e., optional engagement in between scheduled collection) patient engagement in the collection of radiation toxicity outcomes using the M-PART methodology.
• To measure patient and research staff satisfaction, perceptions, and preferences with regard to the M-PART data collection framework.

OUTLINE:

Patients apply KeraStat topically at least twice daily (BID) or more as needed and complete MyCap patient reported dermatitis assessments and submit photographs in MyCap once a week (QW) during RT and for 1 month following treatment in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo clinician skin rash assessments and standardized in-clinic photography on study.

After completion of study intervention, patients may be followed for up to 6 months.

Inclusion Criteria:

- 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.

Exclusion Criteria:

• 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.