This clinical trial studies whether a multi-platform assessment of radiation toxicity (M-PART) can be used to for the collection of patient information on acute radiation dermatitis (RD) in head and neck cancer patients being treated with KeraStat® cream. Radiation therapy (RT) is commonly used for the treatment of head and neck cancer. Acute RD is one of the most common and painful side effects of RT, causing the affected skin to become painful, red, itchy, and blistered. RD can impact quality of life and lead to treatment delays. Managing the symptoms of RD is important to make certain RT is completed in a timely manner. M-PART allows for remote collection of information on RD from the patient using a mobile application (MyCap). The patient completes RD assessments and uploads photos of affected areas that can then be reviewed by the physician. KeraStat is a cream applied to the skin (topical). It contains the naturally-derived biomaterial keratin that has wound repair promoting, hemostatic, and moisturizing activities as well as the potential to protect against damage that may result from exposure to ionizing radiation. Using M-PART to collect patient information on acute RD may be helpful for the physician to review and manage symptoms of RD in head and neck cancer patients being treated with KeraStat. This may allow RT to be completed in a timely manner.
Additional locations may be listed on ClinicalTrials.gov for NCT06441266.
Locations matching your search criteria
United States
North Carolina
Winston-Salem
Wake Forest University Health SciencesStatus: Active
Contact: Ryan T Hughes
Phone: 336-713-3600
PRIMARY OBJECTIVE:
I. 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:
I. To assess agreement between site clinician-rated Common Terminology Criteria for Adverse Events (CTCAE) grade (G) 2+ RD with moist desquamation and patient-reported moist desquamation.
II. To assess the proportion of patient-submitted photographs of skin in the irradiated area that are evaluable for RD assessments by central review.
III. To assess agreement between clinician-rated RD grading, central review of patient-submitted photographs, and central review of standardized clinic photographs.
IV. 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.
V. To measure patient and research staff satisfaction, perceptions, and preferences with regard to the M-PART data collection framework.
EXPLORATORY OBJECTIVES:
I. To estimate the cumulative incidence, time-to-development, and total duration of acute RD in the sample.
II. To quantify patient-reported outcomes of skin-specific toxicity in the sample.
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.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorRyan T Hughes
