Vibrent Smartphone Mobile Application

The proposed study will evaluate the feasibility of the VibrentTM smartphone application to
evaluate radiation-induced mucositis pain "out of the clinic" and it's ability to enhance
adherence to the prophylactic pain management algorithm. Successful completion of the
proposed study will provide the foundation upon which a randomized trial can be conducted
evaluating the efficacy of prophylactic gabapentin / narcotics for various toxicity,
patient-reported and oncologic outcomes in patients receiving head and neck radiotherapy.
Moreover, successful establishment of this pain analgesic approach may have future
implications in other pain models where there is planned neuropathic tissue injury.

Vibrent Management has established a policy and procedure regarding the Privacy of Protected
Health Information (PHI) and Security of Electronic Protected Health Information (EPHI). This
procedure applies to applicable Vibrent employees and contractors associated with the
management of VibrentTM customer's Protected Health Information. VibrentTM products are HIPAA
and HITECH Act compliant, and use the highest quality processes based on ISO13485 standard
during software design and development. VibrentTM quality process has successfully passed
quality audits from leaders in medical devices and pharmaceutical products. The security,
privacy, quality processes and HIPAA compliance of VibrentTM LHS (Learning Healthcare System)
Cloud hosted system has been cleared for commercial use by the DoD (US Army) to provide
remote care management services for soldiers and civilians. In addition, this secure and
HIPAA compliant VibrentTM LHS has received SSAE16 certification to prove operational controls
needed to ensure such compliance.

The Vibrent LHS security components include security of data in flight and data at rest
throughout end-to-end system architecture. VibrentTM mobile and web applications are designed
to be secure in handling information provided and stored within it. All data exchanges
between mobile applications or web browsers and the website are encrypted. Once a complete
patient consult is transmitted from the mobile device and the server acknowledges receipt,
all data and photos would be removed automatically from the mobile device. Data stored in the
mobile application as well as the website is secured and encrypted. Data is exchanged over
the internet securely using HTTPS/SSL.

The VibrentTM server has also been securely integrated with the Johns Hopkins Oncospace®
analytic database server allowing secure one-way secure transmission of "out of clinic"
assessment data to the "in clinic" Oncospace® analytic database which captures all
treatment-related information including all radiotherapy dosimetry information and "in
clinic" treatment toxicities and oncologic and toxicity outcome measures including
patient-reported outcomes. Integration is particularly important as the radiotherapy dose,
volume and the location of the upper aerodigestive tract that is irradiated can all affect
the level of the pain experienced from radiation-induced mucositis. Oncospace® was developed
to handle all continuous data-points in the dose-volume histogram (DVH) which summarizes the
radiotherapy delivered to specific structures delineated in a radiotherapy plan as a series
of analyzable relational tables within a database architecture thus facilitating
quantification of the radiotherapy treatment and how it may affect radiation-induced
mucositis pain.

Inclusion Criteria:

1. Study subjects age ≥ 18 years of age.

2. Study subject with a Karnofsky performance scale of 80 or greater.

3. Study subjects capable of providing informed consent.

4. Study subjects with a previously untreated head and neck cancer diagnosis requiring a
definitive or postoperative course of radiotherapy requiring a prescribed dose of
radiation therapy

5. Study subjects who have either an Android or Apple iOS-based smartphone or tablet
compatible with the VibrentTM software with sufficient monthly data plan
(approximately 200 megabytes per month).

Exclusion Criteria:

a. No known hypersensitivity or intolerance to gabapentin.