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NCT06441266 | RECRUITING | Radiation Dermatitis

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

Wake Forest University Health Sciences

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.

Condition or disease

Radiation Dermatitis

Intervention/treatment

KeraStat cream

M-PART Assessments via MyCap

Clinical Assessments

Feedback phone interview

Phase

NA

Detailed Description:

Primary Objective: To determine the feasibility of M-PART for the assessment of acute radiation dermatitis in patients treated with radiotherapy for head and neck cancer via MyCap. Secondary Objectives: * To assess agreement between site clinician-rated CTCAE G2+ radiation dermatitis with moist desquamation and patient-reported moist desquamation (a and b above). * To assess the proportion of patient-submitted photographs of skin in the irradiated area that are evaluable for radiation dermatitis assessments by central review. * To assess agreement between clinician-rated radiation dermatitis grading, central review of patient-submitted photographs, and central review of standardized clinic photographs (methods a, c, and d above). * To measure the level of interval (i.e., optional engagement in between scheduled collection) patient engagement in the collection of radiation toxicity outcomes using the M-PART methodology. * To measure patient and research staff satisfaction, perceptions, and preferences with regard to the M-PART data collection framework.

Study Type : INTERVENTIONAL
Estimated Enrollment : 16 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2026-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 60 Gy. The 60 Gy RT 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 PI.
  • 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 registration.
  • * History of scleroderma or active lupus requiring systemic medication at the time of registration.
  • * 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.
M-PART in Head and Neck Cancer Patients Treated With KeraStat Cream for Acute Radiation Dermatitis

Location Details

NCT06441266

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Locations

RECRUITING

United States, North Carolina

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157