M-PART in Head and Neck Cancer Patients Treated With KeraStat Cream for Acute Radiation Dermatitis (NCT06441266) | Clinical Trial Compass
CompletedNot Applicable
M-PART in Head and Neck Cancer Patients Treated With KeraStat Cream for Acute Radiation Dermatitis
United States16 participantsStarted 2025-05-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on testing whether the study design itself is feasible — not yet on whether KeraStat Cream definitively works — so what does that mean for what we'd actually learn about managing my radiation dermatitis if I were to participate?
2Since this study is listed as 'active, not recruiting,' does that mean enrollment is already closed, and if so, are there other studies or standard treatments using KeraStat Cream or similar skin care products that I could still access?
3Radiation dermatitis can really affect quality of life during head and neck cancer treatment — what are the currently recommended standard-of-care options for preventing or treating it, and how do they compare to what this trial is testing?
4The trial uses something called M-PART alongside KeraStat Cream — can you explain what M-PART involves in practice and whether the time commitment for the scheduled study assessments would be realistic given my overall treatment schedule?
5Since this appears to be a feasibility study rather than a phase designed to measure clinical outcomes like healing time or pain reduction, would my participation primarily help future patients rather than directly inform my own treatment decisions?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants that Complete Scheduled Study Assessments to Measure for Feasibility
Timeframe: 4 weeks post radiation therapy, up to 2 years