NCT06441266Completed
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
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 29 May 2024
- Start date
- 8 May 2025
- Primary completion date
- 8 Jun 2026
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Head and neck cancer
- NCT number
- NCT06441266
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 8 May 2025 to the primary completion date, 8 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- Individuals who are pregnant or plan to become pregnant. Radiotherapy is contraindicated in this patient population.
Other illness
- History of scleroderma or active lupus requiring systemic medication at the time of enrollment.
Lab values
- Planned concurrent treatment with anti-EGFR biologic therapy (e.g., cetuximab) for head and neck cancer.
Other
- Patients planned for treatment to the primary site alone without regional lymph node targeting.
Who the study is looking for
- \- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.