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

NCT03574870 | Completed FDA Device

• 1 other identifier: STU 102016-059
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Head and Neck

Outcome Measures

Primary Outcomes (2)

• Number of participants who could wear the device more than 90% of the time, of 23 hours a day, daily

  To determine the feasibility of using a commercially-available wearable sensor to obtain biometric data for patients undergoing head and neck locoregional therapy throughout the duration of radiation treatment (cohorts A, B-RT) and throughout post-surgical recovery with or without adjuvant radiotherapy (cohort B)

  3 months

• Daily data acquisition rate

  Percentage of successful data acquisition events as well as a retention rate of all enrolled participants.

  3 months

Secondary Outcomes (10)

• Changes in daily steps taken

  3 months

• Changes in heart rate

  3 months

• Changes in sleep habits

  3 months

• Volume of intravenous fluids

  3 months

• Days of inpatient hospitalization

  3 months

Study Arms (2)

Chemoraditherapy

EXPERIMENTAL

Patients with head and neck cancer require chemo and radiation therapy (Cohort A): A wearable sensor device will be issued at the time of trial enrollment. Patients will be instructed to wear the device on their wrist for 23 hours per day, 7 days per week, from the time of their radiation simulation through one week following the end of radiation treatment

Device: wearable sensor

Primary surgery w/o radiotherapy

EXPERIMENTAL

Patients with head and neck cancer require primary surgery alone (Cohort B-SA) A wearable sensor device will be issued at the time of trial enrollment. Patients will be instructed to wear the device on their wrist for 23 hours per day, 7 days per week, from one week before surgery through 1 month following surgery Patients with head and neck cancer require primary surgery and postoperative radiotherapy (Cohort B-RT) A wearable sensor device will be issued at the time of trial enrollment. Patients will be instructed to wear the device on their wrist for 23 hours per day, 7 days per week, from one week before surgery to one week following the end of radiation treatment .

Device: wearable sensor

Interventions

wearable sensor DEVICE

A commercially-available wearable fitness sensor

Also known as: FITBIT

Chemoraditherapy; Primary surgery w/o radiotherapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥ 18 years.
• 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.
• 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).
• Concurrent chemotherapy is required for definitive radiotherapy patients
• Hypofractionated or stereotactic body radiation therapy is not permitted
• Ability to understand and the willingness to sign a written informed consent
• Willingness to download the Fitbit App to a personal mobile device

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• David Sher, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: July 2, 2018
• Study Start: October 30, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

US (1)