Using a mobile app to track skin reactions in head and neck cancer patients receiving radiation therapy
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
This study is testing a mobile app to see if it can help head and neck cancer patients track their skin reactions during radiation therapy and how well they feel about using it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | cetuximab, radiation |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06441266 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using a mobile application called MyCap to collect information on acute radiation dermatitis in patients with head and neck cancer undergoing radiation therapy. The primary objective is to assess the effectiveness of the M-PART methodology in monitoring skin reactions. Secondary objectives include comparing clinician assessments with patient-reported outcomes and evaluating the quality of patient-submitted photographs for central review. The study also aims to measure patient engagement and satisfaction with the data collection process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of head and neck cancer who are scheduled to receive radiation therapy.
Not a fit: Patients who are not undergoing radiation therapy or those with non-invasive head and neck cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the monitoring and management of radiation dermatitis, improving patient comfort and treatment outcomes.
How similar studies have performed: While the use of mobile applications for patient monitoring is gaining traction, this specific approach to assessing radiation dermatitis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Ryan T Hughes, MD — Wake Forest Baptist Comprehensive Cancer Center
- Study coordinator: Principal Investigator
- Email: ryhughes@wakehealth.edu
- Phone: 336-713-3600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.