Clinical trial · Interventional
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
NCT06441266CI-TRIAL-00116833completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical Assessments | Other | — | UNRESOLVED |
| Feedback phone interview | Other | — | UNRESOLVED |
| KeraStat cream | Drug | — | UNRESOLVED |
| M-PART Assessments via MyCap | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- M-PART Assessment via MyCap
- description
- Assessment through the MyCap app to assess radiation dermatitis with the use of Kerastat cream.
- interventionNames
- Drug: KeraStat cream
- Device: M-PART Assessments via MyCap
- Other: Clinical Assessments
- Other: Feedback phone interview
Primary outcomes (1)
- measure
- Number of Participants that Complete Scheduled Study Assessments to Measure for Feasibility
- timeFrame
- 4 weeks post radiation therapy, up to 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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.
References
Publications (0)
Data not yet available
No reference posted for this study.