Commensal Oral Microbiota in H&N Cancer

Patients will be randomized in a 1:1 ratio to two different oral care protocols within 4
strata defined by type of RT (Proton beam therapy (Protons)) vs intensity-modulated radiation
therapy (IMRT) and cancer treatment (RT versus chemoRT). Eligible subjects will be assigned
to receive either the Oral Mucosal Deterging and Dental Prophylaxis protocol (OMDP) or a
Standard of Care Oral Hygiene protocol (SOC-OH). Prior to randomization, all enrolled
subjects will receive a baseline dental prophylaxis and fluoride varnish application prior to
start of RT or chemoRT to ensure that all subjects enter the study with comparable oral
health. Subjects assigned to OMDP will receive the OMDP Protocol (Oral Mucosal Deterging and
Dental Prophylaxis) at weekly intervention visits. Subjects randomized to the SOC-OH will
receive oral health instructions following the American Dental Association Guidelines1 and
will have their teeth cleaned (brushed) during weekly intervention visits; no treatment to
the oral mucosa will be provided to this group.

At each bi-weekly study visit, study assessments will include the collection of saliva and
oral mucosal swabs, an oral exam and OM assessment, and the completion of questionnaires.
During the course of the study, subjects will attend one baseline visit, up to 9 intervention
visits, and a follow-up visit approximately 2 months after completion of RT. Local supportive
care, including normal saline rinses, topical anesthetics, mixed medication mouthwashes (e.g.
Magic Mouthwash), feeding tubes, and pain management will be allowed according to each
recruitment site's standard of care procedures.

Inclusion 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.

Exclusion Criteria:

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 prophylaxis 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).