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

Phase

N/A

Condition

Allergy

Rash

Treatment

M-PART Assessments via MyCap

Feedback phone interview

Clinical Assessments

Clinical Study ID

NCT06441266

IRB00115715

ONC-HN-2404

P30CA012197

Ages > 18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 inthe MyCap application using their personal mobile device.
Ability to understand and the willingness to sign an IRB-approved informed consentdocument (either directly or via a legally authorized representative) in English.

Exclusion

Exclusion Criteria:

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

Study Design

M-PART Assessments via MyCap

May 08, 2025

July 31, 2026

Study Description

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.

Connect with a study center

Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina 27157
United States
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.