RecruitingNot ApplicableNCT06441266

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

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


Sponsor

Wake Forest University Health Sciences

Enrollment

16 participants

Start Date

May 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests KeraStat Cream — a topical skin treatment — for helping prevent or heal radiation dermatitis, the painful, inflamed skin reaction that commonly occurs during radiation therapy for head and neck cancer. The M-PART method combines nursing assessments with patient self-reporting for comprehensive monitoring. **You may be eligible if...** - You have been diagnosed with head and neck cancer (including cancers of the mouth, throat, voice box, or sinuses) - You are scheduled to receive standard radiation therapy (at least 60 Gy total dose) to the head and neck area **You may NOT be eligible if...** - You are receiving a non-standard radiation schedule - You have a skin condition that would interfere with evaluation of radiation dermatitis - You are unable to provide consent or attend required study visits Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKeraStat 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

DEVICEM-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

OTHERClinical 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.

OTHERFeedback phone interview

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


Locations(1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

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NCT06441266


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