Clinical trial NCT06441266: M-PART in Head and Neck Cancer Patients Treated With KeraStat Cream for Acute Radiation Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiation Dermatitis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-06-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 60 Gy. The 60 Gy RT 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 PI.

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 registration.
* History of scleroderma or active lupus requiring systemic medication at the time of registration.
* 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.

Primary outcomes:
measure: Number of Participants that Complete Scheduled Study Assessments to Measure for Feasibility
timeFrame: 2 years
Secondary outcomes:
measure: Number of Participants to Self-Report Presence of Radiation Dermatitis Compared to Site Clinician Reported Radiation Dermatitis.
timeFrame: At baseline, weekly during radiation therapy, weekly for 4 weeks post radiation therapy, up to 2 years
measure: Percentage of Participant-Submitted Photographs Evaluable for Radiation Dermatitis Grading
timeFrame: At baseline, weekly during radiation therapy, weekly for 4 weeks post radiation therapy, up to 2 years
measure: Proportion of Agreement in Grading Methods for Radiation Dermatitis
timeFrame: At baseline, weekly during radiation therapy, weekly for 4 weeks post radiation therapy, up to 2 years
measure: Number of Skin Assessments Provided Through MyCap - Patient Engagement
timeFrame: At baseline, weekly during radiation therapy, weekly for 4 weeks post radiation therapy, up to 2 years
measure: Frequency in Responses to Satisfaction with M-PART - Semi-Quantitative Survey
timeFrame: 4 weeks after completion of radiation therapy, up to 2 years
measure: Frequency in Responses to Satisfaction with M-PART - Qualitative Interviews
timeFrame: 4 weeks after completion of radiation therapy, up to 2 years
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Ryan T Hughes, MD
role: PRINCIPAL_INVESTIGATOR
References: