Perlmutter Cancer Center

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Oral Mucositis
• Age: Between 22 years - 100 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  Subjects must meet all the following Inclusion Criteria to participate in this Adult Patients with Head and Neck Cancer study: 1. Subject has been diagnosed with pathologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, tonsil or base of tongue. 2. Within 28 days of Screening, subject is scheduled to receive a continuous course of Intensity-Modulated Radiation Therapy (IMRT) over an estimated 6 to 8 weeks (treatment week is defined as 5 fractions per week). The initial target volume encompassing the gross and subclinical disease sites will receive 5 fractions per week with a minimum cumulative dose of 50 Gray (Gy) for low to intermediate risk (sites of suspected subclinical spread) and maximum cumulative dose of 70 Gy for gross tumor volume/High risk (Primary tumor and involved lymph nodes). 3. The subject’s planned radiation treatment fields include at least one oral site (buccal mucosa, floor of mouth, ventral/lateral tongue, soft palate, oropharynx). 4. The subject’s treatment plan includes chemotherapy with cisplatin administered in either a standard weekly (30-40 mg/m2) or approximately every 21 days (80-100mg/m2) regimen AND/OR paclitaxel administered in a standard weekly (30-45mg/m2) regimen in combination with carboplatin administered in standard weekly (1.0-2.0 AUC) regimen. 5. Subject is at least 22 years of age. 6. Subject has no dental or oral health conditions that would preclude daily use of a mouthpiece. 7. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of = 2.; 8. Subject is able to read and understand the Informed Consent Form (ICF) and has voluntarily provided written informed consent. 9. Subject demonstrates capability in sustaining mouthpiece in oral cavity for recommended time during Screening procedure. 10. Subject demonstrates willingness to adhere to the prohibitions and restrictions specified in this protocol.
  

You may not be eligible for this study if the following are true:

• Any patient who meets any of the exclusion criteria will be excluded from participation in this study: 1. Subject is currently receiving or has previously received chemotherapy or chemoradiotherapy within the past 2 years. 2. Subject has previously been diagnosed with another type/site of cancer that has not been controlled or has been active in the past 2 years. 3. Subject is pregnant or nursing. 4. Subject is receiving medications indicated for the treatment and/or prevention of mucositis (e.g., palifermin). 5. Subject has had prior radiation to the head and neck. 6. Subject has a diagnosis that is prone to affect wound healing, e.g., uncontrolled diabetes. 7. Subject has trismus with an interincisal distance of 30mm or less, 8. Subject has an active infection in the oropharyngeal cavity. 9. Subject has a salivary disturbance, e.g., Sjögren's syndrome. 10. Subject has any grade of oral mucositis (per WHO Oral Toxicity Scale). 11. Subject is receiving, or has received in the last 30 days, an investigational treatment, therapy, or medical device outside of this clinical study protocol. 12. Subject has a VAS score of 50 mm or greater localized to the oral cavity but is NOT tumor related. 13. Subject is unable to participate in the study because of a concurrent disease state that, in the opinion of the Principal Investigator, would affect the study endpoints, e.g., dental disease. 14. Subject is currently using, and/or has used in the last 30 days, any tobacco or nicotine products, with the exception of nicotine patches. 15. Subject is currently taking, or has taken in the last month, any marijuana (Cannabis sativa or Cannabis indica), or illicit drugs. 16. Subject has 8 or more crowns OR subject is not considered eligible at the discretion of the oral maxillofacial dentist/surgeon.