Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer

Overview

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.

Full Title of Study: “A Prospective, Multi-Center Investigational Study of Heart Rate Variability Monitoring for the Early Detection of Pancreatic Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 30, 2022

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 determine whether HRV is reduced in participants at high-risk of developing PDAC. (Stage II) III. To characterize timing and occurrence of PDAC among high-risk without disease. (Stage II) IV. 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)

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.

Interventions

  • Device: Activity Monitor
    • Undergo HRV monitoring via WHOOP device
  • Other: Quality-of-Life Assessment
    • Ancillary studies
  • Other: Questionnaire Administration
    • Complete questionnaires

Arms, Groups and Cohorts

  • Observational (HRV monitoring, questionnaire)
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Magnitude of heart rate variability (HRV) decline (Stage I)
    • Time Frame: Up to 1 year after enrollment
    • As measured by root mean square of the successive differences (RMSSD) in pancreatic ductal adenocarcinoma (PDAC) patients and in high-risk participants.
  • Compliance statistics for wristband use (Stage II)
    • Time Frame: Until onset of PDAC, study withdrawal, or death, whichever occurs first, assessed up to 5 years after enrollment
    • Defined as the percentage of days during which data were collected during at least 70% of the hours.

Secondary Measures

  • Compliance statistics for wristband use for all participants (Stage I, II)
    • Time Frame: Up to 6 weeks and 6 months after enrollment and device activation
    • Defined as the percentage of days during which data were collected for at least 70% of the hours.
  • Magnitude of HRV change (Stage II)
    • Time Frame: Up to 5 years post enrollment
    • As measured by RMSSD, in participants at high-risk of developing PDAC.
  • Incidence of PDAC among high-risk participants (Stage II)
    • Time Frame: Up to 5 years post enrollment
  • Time of PDAC diagnosis among high-risk participants who developed PDAC (Stage II)
    • Time Frame: Up to 5 years post enrollment

Participating in This Clinical Trial

Inclusion Criteria

  • Ability to understand and the willingness to sign a written informed consent document
  • Own a smartphone that uses Android or Apple iOS operating systems
  • Participant must have one of the following:
  • Individuals with newly-diagnosed, treatment naive PDAC – all stages (applicable to Stage 1 only), or
  • Individuals with at least one of the following family phenotype and age will be included:
  • Two or more relatives with PDAC on the same side of the family, where 2 PDAC affected individuals are first-degree related (FDR) AND at least one PDAC-affected individual is an FDR of the subject; Age >=50 years OR 10 years before onset in family
  • Two affected FDR with PDAC; Age >= 50 years OR 10 years before onset of an FDR
  • Any of BRCA1, BRCA2, PALB2, ATM mutations confirmed pathogenic or likely pathogenic; Age >= 50 years OR 10 years before onset of an FDR or second-degree relative (SDR)
  • FAMMM with confirmed pathogenic or likely pathogenic mutation variants in: p16, CDKN2A; Age >= 50 years
  • Known mutation carrier for STK11 (Peutz-Jeghers syndrome); Age >= 35 years
  • Lynch syndrome (hereditary nonpolyposis colorectal cancer [HNPCC]) with confirmed pathogenic or likely pathogenic variants in: MLH1, MSH2, MSH6, PMS2, or EPCAM; Age >= 50 years OR 10 years before onset of an FDR or SDR
  • Hereditary pancreatitis with confirmed PRSS1 pathogenic or likely pathogenic history of pancreatitis; Age >= 40 years

Exclusion Criteria

  • Any medical conditions that in the opinion of the investigators would compromise participant safety and/or the integrity of the data

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • OHSU Knight Cancer Institute
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Aaron Grossberg, Principal Investigator – OHSU Knight Cancer Institute
  • Overall Official(s)
    • Aaron Grossberg, Principal Investigator, OHSU Knight Cancer Institute

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