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:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT00574860
Eligibility Criteria:
Significant Inclusion Criteria:
* 18 years and older
* newly diagnosed SCC of the oral cavity and/or oropharynx, and are intended for treatment with ChemoRT.
* Have a clinical plan to receive a minimum of 60 Gy to the oral cavity and/or oropharynx
* Chemotherapy: cisplatin
* Have a WBC ≥3500 per cubic millimeter
* Have a platelet count ≥100,000 per cubic millimeter
* Have adequate renal function as determined by the principal investigator prior to enrollment
* Are willing and able to undergo oral assessments
* Have a Karnofsky Performance Status score ≥70
Significant Exclusion Criteria:
* Have OM or other oral conditions at study entry
* Plan to use Amifostine, Pilocarpine, Cevimeline or Bethanechol
* Are using a pre-existing feeding tube for nutritional support at study entry
* Plan to use any drug for the treatment or prevention of OM
* Have had any prior radiotherapy to the head and neck
* Have had prior chemotherapy within 6 months preceding enrollment
* Plan to have concurrent chemotherapy, other than those regimens specified under inclusioncriteria
* Have received other investigational drugs in the 30 days preceding initiation of study drug or during administration of study drug
* Have medical conditions that require the use of chronic steroid therapy
* Have the inability to undergo repeat treatments,
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00574860
Study Brief:
Protocol Section:
NCT00574860