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

Completed · Not applicable

Conditions studied: Cancer of Head and Neck

In brief

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.

Key facts

Study ID

NCT03574870

Run by

University of Texas Southwestern Medical Center

People needed

53

Starts

2017-10-30

Expected to finish

2019-12-31

Last updated by the study team

2021-01-15

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

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.
• 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).
• 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.

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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