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ACTIVE NOT RECRUITING

NCT06441266

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

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05-08

Completion Date

2026-07

Last Updated

2026-04-03

Healthy Volunteers

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.

Inclusion Criteria: \- Histological or cytological diagnosis of head and neck cancer (of any part of the oral cavity, pharynx, larynx, or sinuses) planned to receive conventionally fractionated radiation therapy (RT) targeting the head and neck to a total prescribed dose of at least 50 Gy. The 50 Gy radiation therapy target must include at least a part of the unilateral and/or bilateral lymph node regions of the head/neck. Planned prescribed dose will be reviewed and approved by the study principal investigator. NOTE: Patients without a clear pathologic diagnosis of invasive disease (i.e., biopsy showing at least carcinoma in situ) but with clinically diagnosed head and neck cancer planned for treatment as above are also eligible. * Age ≥ 18 years at the time of enrollment. * Able and willing to complete electronic toxicity and quality of life assessments in the MyCap application using their personal mobile device. * Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative) in English. Exclusion Criteria: * Early stage (Stage I-II) squamous cell carcinoma of the glottic larynx planned for treatment with limited field radiation therapy alone. These participants are excluded since they are expected to receive a more limited exposure to radiation therapy. * Patients planned for treatment to the primary site alone without regional lymph node targeting. * Previous radiation therapy to the area in the head and neck to be treated with radiation therapy. * Active use of topical corticosteroids in the irradiation area at the time of enrollment. Note that it is acceptable to use topical corticosteroids if study participants develop moist desquamation during radiation therapy. * History of scleroderma or active lupus requiring systemic medication at the time of enrollment. * Planned concurrent treatment with anti-EGFR biologic therapy (e.g., cetuximab) for head and neck cancer. * Individuals who are pregnant or plan to become pregnant. Radiotherapy is contraindicated in this patient population.

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States