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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT02682992
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to understand and sign informed consent form approved by the HRPO.
* Males or females greater than or equal to 18 years old.
* Biopsy-proven HNC including cancers of the nasopharynx, oropharynx, larynx, hypopharynx, or HNC of unknown primary origin amenable to therapy with radiation and concurrent chemotherapy.
* Patients who are planned to receive definitive or adjuvant radiotherapy with concurrent platinum-based chemotherapy.
* Patients whose clinical treatment plans include a continuous course of external beam radiotherapy by intensity-modulated radiation therapy (IMRT) and/or image-guided radiation therapy (IGRT), given as a cumulative dose of 5000 - 7000 cGy in single daily fractions of 180 - 200 cGy, combined with a concurrent course of weekly or tri-weekly cisplatin or carboplatin chemotherapy.
* Karnofsky performance status score \>60.
* Female subjects of child-bearing potential must have a negative pregnancy test prior to enrollment.
Exclusion Criteria:
* Subject has evidence of current mucositis, mucosal ulceration, or unhealed surgical wounds from surgical resection or biopsy.
* Prior radiation to the head and neck.
* Patients with gross tumor involvement of the oral cavity or oral mucosa.
* Subjects planned to receive altered fractionation radiotherapy or multiple fractions per day
* Subject is using a pre-existing feeding tube for nutritional support at the time of study entry.
* Women who are pregnant or breast-feeding.
* Subject plans to receive concurrent chemotherapy, other than the regimens specified in the inclusion criteria.
* Patients who have chronic immunosuppression or are on current immunosuppressive therapies.
* Patients who have a contraindication to radiation therapy.
* Patients enrolled on another investigational trial for oral mucositis prevention.
* Life expectancy of less than 3 months.
* Unable or unwilling to adhere to study-specified procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02682992
Study Brief:
Protocol Section:
NCT02682992