NCT04400903

Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer

A Prospective, Multi-Center Investigational Study of Heart Rate Variability Monitoring for the Early Detection of Pancreatic Cancer

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study examines heart rate monitoring variability for the early detection of pancreatic cancer. Pancreatic cancer is a very difficult disease to detect early. This study is being done to observe the heart rate variability in patients with pancreatic cancer compared to undiagnosed individuals with increased risk of developing pancreatic cancer. This may help researchers determine if pancreatic occurrences/recurrences (chance of coming back) can be detected sooner through monitoring heart rate and activity.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether heart rate variability (HRV) is reduced in patients with pancreatic ductal adenocarcinoma (PDAC) compared with individuals at increased risk of developing PDAC. (Stage I) II. To assess the feasibility of long-term compliance using a wearable device. (Stage II) SECONDARY OBJECTIVES: I. To assess compliance with using a wearable device. (Stage I and II) II. To validate effectiveness of virtual device training. (Stage I and II) III. To determine whether HRV is reduced in participants at high-risk of developing PDAC. (Stage II) IV. To characterize timing and occurrence of PDAC among high-risk without disease. (Stage II) V. To characterize timing and occurrence of PDAC among participants at high-risk of developing PDAC. (Stage II) EXPLORATORY OBJECTIVES: I. To investigate the relationship between changes in HRV relative to sarcopenia-related body composition characteristics in PDAC patients. (Stage I) II. To investigate the relationship between the pNN50 HRV measure and PDAC diagnosis. (Stage I and II) III. To compare changes in sleep biometrics among all participants. (Stage I and II) IV. To evaluate changes in health-related quality of life assessments among all participants. (Stage I and II) V. To evaluate participant satisfaction with virtual device instruction. OUTLINE: Participants undergo HRV monitoring using an activity monitor (WHOOP) for a minimum of 5 days weekly for up to 1 year in patients with newly-diagnosed PDAC and up to 5 years for patients in high risk group.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Stage I Pancreatic Cancer AJCC v8
• Stage IA Pancreatic Cancer AJCC v8
• Stage IB Pancreatic Cancer AJCC v8

Interventions

Type	Name	Description
DEVICE	Activity Monitor	Undergo HRV monitoring via WHOOP device
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2020-09-21
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2020-05-26
• Last updated: 2022-11-22

Locations

3 sites across 1 country: United States