Clinical trial · Interventional
Wearable Sensor for Biometrics During Locoregional Therapy for Head and Neck Cancer
Feasibility Study of a Wearable Sensor for Acquisition of Biometric Data in Head and Neck Cancer Patients During Locoregional Therapy
NCT03574870CI-TRIAL-00049469FITBITcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| wearable sensor | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemoraditherapy
- description
- 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
- interventionNames
- Device: wearable sensor
- type
- EXPERIMENTAL
- label
- Primary surgery w/o radiotherapy
- description
- 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 .
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.