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

NCT06441266 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-04-03

No results posted yet for this 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.

Conditions

  • Radiation Dermatitis

Interventions

DRUG

KeraStat cream

KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions. The intervention is a topical cream applied at least twice daily starting at start of radiation therapy until 1-month from the end of radiation therapy completion

DEVICE

M-PART Assessments via MyCap

The M-PART approach harnesses the remote data collection capabilities of MyCap to facilitate remote collection or data including but not limited to toxicity assessments, quality of life surveys, and patient-provided photographs of the skin in the treated area

OTHER

Clinical Assessments

Participants will undergo assessments at baseline (prior to radiation therapy start), weekly during and after radiation therapy until 1-month post-radiation therapy. Medical history will be collected at baseline including primary cancer site, HPV status (if oropharyngeal cancer primary), laterality, TNM classification, stage, surgical resection prior to radiation therapy, weight, body mass index and patient self-reported Fitzpatrick skin phototype.

OTHER

Feedback phone interview

Participant satisfaction, perceptions and preferences with using M-PART will be discussed.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Ryan T Hughes, MD · Wake Forest Baptist Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-08
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06441266 on ClinicalTrials.gov