Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04400903
• Other study ID #: STUDY00021185
• Secondary ID: NCI-2020-03178ST
• Status: Terminated
• Start date: September 21, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Activity Monitor
Undergo HRV monitoring via WHOOP device

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	Laura and Isaac Perlmutter Cancer Center at NYU Langone	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	American Association for Cancer Research, National Cancer Institute (NCI), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Magnitude of HRV change (Stage II)	As measured by RMSSD, in participants at high-risk of developing PDAC.	Up to 5 years post enrollment
Secondary	Incidence of PDAC among high-risk participants (Stage II)		Up to 5 years post enrollment
Secondary	Time of PDAC diagnosis among high-risk participants who developed PDAC (Stage II)		Up to 5 years post enrollment