Commensal Oral Microbiota in Head and Neck Cancer (ARMOR)

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head Cancer, Neck Cancer, Oral Mucositis, Oral Health, Radiation, Chemoradiation Read More

Currently enrolling subjects receiving intensity-modulated radiation therapy (IMRT), with or without chemotherapy.

Subject Inclusion Criteria

To participate in this study, an individual must meet all the following criteria:

1. 18 years of age or older;
2. Able and willing to provide informed consent prior to initiation of study procedures;
3. Scheduled to undergo radiation or chemoradiation treatment for head/neck cancer;
4. Presents with at least one of nine areas of the oral or oropharyngeal mucosa (i.e., upper lip, lower lip, right cheek, left cheek, right ventral and lateral tongue, left ventral and lateral tongue, floor of the mouth, and soft palate) expected to receive at least 5000 cGy of RT. Patients with cancer located outside of the oral cavity will be included when at least 5000 cGy of RT will be administered to the oral cavity in addition to the RT targeted at the primary cancer site.
5. Presents with a minimum of 6 natural teeth.

Subject Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Pregnant or lactating at the baseline/screening visit;
2. Participating in another oral health interventional research study at any point during their participation in this trial;
3. Receiving induction chemotherapy or concurrent radiation therapy with cetuximab;
4. Reports current use of antifungal or antibiotic at the time of enrollment;
5. Presents with immunocompromised status (defined as an absolute neutrophil count (ANC) of less than 1000);

6. Presents with any of the following conditions, which based on American Dental and American College of Cardiology guidelines, require antibiotic prophylaxis prior to dental treatment:

   1. prosthetic cardiac valves, including transcatheter-implanted prostheses and homografts;
   2. prosthetic material used for cardiac valve repair, such as annuloplasty rings and chords;
   3. a history of infective endocarditis;
   4. a cardiac transplant with valve regurgitation due to a structurally abnormal valve;
   5. the following congenital (present from birth) heart disease: unrepaired cyanotic congenital heart disease, including palliative shunts and conduits; or any repaired congenital heart defect with residual shunts or valvular regurgitation at the site of or adjacent to the site of a prosthetic patch or a prosthetic device;
7. Presents with cardiovascular implantable electronic devices (CIEDs) such as pacemakers, and implantable cardioverter-defibrillators; unless, a) in the opinion of the investigator, the OMDP protocol can be performed with hand scalers (and not with an ultrasonic device as per protocol) or upon consult with the treating cardiologist, it is determined that the ultrasonic device can be safely used;
8. Presents with severe periodontal disease for which treatment cannot be completed prior to the start of radiation/chemoradiation (at the discretion of the investigator);
9. Had surgery as part of cancer treatment and is not sufficiently healed to comply with study requirements prior to RT initiation;
10. In the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. cognitive or physical impairment).