Clinical trial NCT03574870: Wearable Sensor for Biometrics During Locoregional Therapy for Head and Neck Cancer
Official title: Feasibility Study of a Wearable Sensor for Acquisition of Biometric Data in Head and Neck Cancer Patients During Locoregional Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Head and Neck
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who could wear the device more than 90% of the time, of 23 hours a day, daily
timeFrame: 3 months
measure: Daily data acquisition rate
timeFrame: 3 months
Secondary outcomes:
measure: Changes in daily steps taken
timeFrame: 3 months
measure: Changes in heart rate
timeFrame: 3 months
measure: Changes in sleep habits
timeFrame: 3 months
measure: Volume of intravenous fluids
timeFrame: 3 months
measure: Days of inpatient hospitalization
timeFrame: 3 months
measure: Changes in pain level
timeFrame: 3 months
measure: Number of emergency department visits.
timeFrame: 3 months
measure: Utilization of pain medication
timeFrame: 3 months
measure: Physical and mental well-being
timeFrame: 3 months
measure: Sleep quality
timeFrame: 3 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: David Sher, MD
role: PRINCIPAL_INVESTIGATOR
References: