Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT06441266
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06441266
Study Brief:
Protocol Section:
NCT06441266