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

NARecruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

May 8, 2025

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

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.

Trial Locations (1)

27157

RECRUITING

Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Wake Forest University Health Sciences

OTHER

NCT06441266 - M-PART in Head and Neck Cancer Patients Treated With KeraStat Cream for Acute Radiation Dermatitis | Biotech Hunter | Biotech Hunter