Monitoring Heart Rate Variability For The Early Detection Of Pancreatic Cancer

Study Overview

Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer

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.

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.

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

DEVICE: Activity Monitor
OTHER: Quality-of-Life Assessment
OTHER: Questionnaire Administration

STUDY00021185
NCI-2020-03178 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
STUDY00021185 (OTHER Identifier) (OTHER: OHSU Knight Cancer Institute)
R01CA264133 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-05-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-11-17
First Submitted that Met QC Criteria 2020-05-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-11-22
First Posted (ACTUAL) 2020-05-26	Results First Posted N/A	Last Verified 2022-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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.	DEVICE: Activity Monitor Undergo HRV monitoring via WHOOP device OTHER: Quality-of-Life Assessment Ancillary studies OTHER: Questionnaire Administration Complete questionnaires

Participant Group/Arm

Intervention/Treatment

: 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.

DEVICE: Activity Monitor

Undergo HRV monitoring via WHOOP device

OTHER: Quality-of-Life Assessment

Ancillary studies

OTHER: Questionnaire Administration

Complete questionnaires

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

Secondary Outcome Measures	Measure Description	Time Frame
Compliance statistics for wristband use for all participants (Stage I, II)	Defined as the percentage of days during which data were collected for at least 70% of the hours.	Up to 6 weeks and 6 months after enrollment and device activation
Effectiveness of virtual training (Stage I, II)	Defined as the percentage of participants for whom high quality data are available within 3 days of set up. The pattern of missing data, and the percentage of participants able to collect data will be presented graphically. Will also associate the compliance with patient characteristics, regions and seasons to understand what may impact the compliance rate.	Up to 1 week after enrollment and device activation
Magnitude of HRV change (Stage II)	As measured by RMSSD, in participants at high-risk of developing PDAC.	Up to 5 years post enrollment
Incidence of PDAC among high-risk participants (Stage II)		Up to 5 years post enrollment
Time of PDAC diagnosis among high-risk participants who developed PDAC (Stage II)		Up to 5 years post enrollment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
50 Years

Accepts Healthy Volunteers:
1

Ability to understand and the willingness to sign an 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)
Familial atypical multiple mole-melanoma (FAMMM) with confirmed pathogenic or likely pathogenic mutation variants in: p16, CDKN2A; Age >= 50 years
Known mutation carrier for STK11 (Peutz-Jeghers syndrome); Age >= 50 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 >= 50 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Oregon Health and Science University
American Association for Cancer Research
National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Aaron Grossberg, OHSU Knight Cancer Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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