New cream and app aim to ease radiation burns for cancer patients
NCT ID NCT06441266
First seen Jun 25, 2026 · Last updated Jul 07, 2026 · Updated 5 times
Summary
This pilot study tests whether a special cream (KeraStat) and a mobile app (MyCap) can help manage skin rashes caused by radiation therapy in head and neck cancer patients. Sixteen participants will apply the cream at least twice daily during radiation and use the app to report their symptoms. The main goal is to see if this approach is practical for a larger future study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KeraStat cream (a protective emollient-based wound dressing applied topically)
- What this could lead to
- If successful, this approach could make it easier for patients to track and manage radiation skin rashes from home, improving comfort and reducing clinic visits.
- What could go wrong
- This is a very small pilot study (16 people) focused on feasibility, not on proving the cream works. The results may not apply to all patients or settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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16 people
The number who actually took part.
- Started
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May 2025
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Five days of radiation instead of weeks: a new test for head and neck cancer
- Can an online program ease the burden on cancer caregivers?