Wearable Sensor for Biometrics During Locoregional Therapy for Head and Neck Cancer

Active cancer treatment such as surgery, chemotherapy or radiotherapy can cause side effects
or toxicities, which, if untreated, can lead to poorer quality of life, decreased patient
well-being, and worse clinical outcomes. Routine monitoring of patients while under active
treatment can entail the routine practice of clinic visits at regular intervals with the
acquisition of vital signs, routine laboratory testing, patient-reported outcome surveys, and
face-to-face interaction with their physician.

In recent years, the availability of commercially-available wearable fitness sensors has
allowed end-users to monitor their fitness progress and activity levels. These devices depend
on small sensors that can collect minute-to-minute data on heart rate and activity level that
may be transmitted to a smartphone or computer. Through this system, users can easily track
and monitor their fitness progress.

In this trial, the investigator will seek to determine the feasibility of wearable biometric
sensors to acquire high resolution biometric data, including heart rate and activity level
(i.e. steps) for patients undergoing radiation therapy and surgery, with or without
postoperative radiotherapy. The investigator believe that changes in heart rate may predict
for increasing pain, dehydration, and stress in general. Moreover, changes in daily step
count are a surrogate for performance status on treatment, and the investigator will perform
a series of preliminary analyses to assess whether there is validity to this hypothesis. The
investigator hope to use biometric monitoring to identify patients at risk for adverse
outcomes, with the ultimate goal of intervening before these outcomes occur.

Inclusion Criteria:

1. Biopsy-proven malignancy requiring chemoradiation therapy to the head and neck, OR
primary surgery to the head and neck, with or without adjuvant radiotherapy or
chemoradiotherapy.

2. Age ≥ 18 years.

3. Performance status ECOG 0-2

Per typical radiotherapy policy, women of child-bearing potential and men must agree
to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry.

3.1 A female of child-bearing potential is any woman (regardless of sexual
orientation, having undergone a tubal ligation, or remaining celibate by choice) who
meets the following criteria:

- Has not undergone a hysterectomy or bilateral oophorectomy; or

- Has not been naturally postmenopausal for at least 12 consecutive months (i.e.,
has had menses at any time in the preceding 12 consecutive months).

4. Concurrent chemotherapy is required for definitive radiotherapy patients

5. Hypofractionated or stereotactic body radiation therapy is not permitted

6. Ability to understand and the willingness to sign a written informed consent

7. Willingness to download the Fitbit App to a personal mobile device

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

2. Subjects must not be pregnant or nursing due to the potential for congenital
abnormalities and the potential of this regimen to harm nursing infants.