Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-27 @ 8:40 PM
Study NCT ID:
NCT06441266
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2024-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
M-PART in Head and Neck Cancer Patients Treated With KeraStat Cream for Acute Radiation Dermatitis
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA012197 | NIH | None | https://reporter.nih.gov/quic… | View |
| ONC-HN-2404 | OTHER | AHWFBCCC | View |