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

NCT06441266 | Recruiting DMC FDA Device

• 3 other identifiers: IRB00115715P30CA012197ONC-HN-2404
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants that Complete Scheduled Study Assessments to Measure for Feasibility

  Participants to complete 75% or more of required assessments over the course of the study will be calculated in two steps. First, investigators will separate patients into two groups, those who have completed 75% or more of their scheduled assessments over all time periods, and those who have not. Investigators will then divide the former number by the total number of patients who completed the study (i.e., completed their radiation treatment) with a final anticipated analyzable number of 16, using a 95% confidence interval. Thus, if 50% or more of the patients in the sample have completed at least 75% of scheduled assessments, the study will be deemed feasible to conduct a future study using M-PART.

  4 weeks post radiation therapy, up to 2 years

Secondary Outcomes (6)

• Number of Participants to Self-Report Presence of Radiation Dermatitis Compared to Site Clinician Reported Radiation Dermatitis.

  At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years

• Percentage of Participant-Submitted Photographs Evaluable for Radiation Dermatitis Grading

  At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years

• Proportion of Agreement in Grading Methods for Radiation Dermatitis

  At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years

• Number of Skin Assessments Provided Through MyCap - Patient Engagement

  At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years

• Frequency in Responses to Satisfaction with M-PART - Semi-Quantitative Survey

  4 weeks after completion of radiation therapy, up to 2 years

Study Arms (1)

M-PART Assessment via MyCap

EXPERIMENTAL

Assessment through the MyCap app to assess radiation dermatitis with the use of Kerastat cream.

Drug: KeraStat cream; Device: M-PART Assessments via MyCap; Other: Clinical Assessments; Other: Feedback phone interview

Interventions

KeraStat cream DRUG

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

M-PART Assessment via MyCap

M-PART Assessments via MyCap DEVICE

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

M-PART Assessment via MyCap

Clinical Assessments OTHER

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.

M-PART Assessment via MyCap

Feedback phone interview OTHER

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

M-PART Assessment via MyCap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Ryan T Hughes, MD

  Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

3367165772; Efrat.Tsivian@Advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: May 8, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)