Clinical trial NCT04400903: Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer
Official title: A Prospective, Multi-Center Investigational Study of Heart Rate Variability Monitoring for the Early Detection of Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pancreatic Ductal Adenocarcinoma
Stage I Pancreatic Cancer AJCC v8
Stage IA Pancreatic Cancer AJCC v8
Stage IB Pancreatic Cancer AJCC v8
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: American Association for Cancer Research
name: National Cancer Institute (NCI)
First posted: 2020-05-26
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with PDAC and participants at high risk for PDAC at Oregon Health and Science University, New York University and University of Nebraska Medical Center

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Magnitude of heart rate variability (HRV) decline (Stage I)
timeFrame: Up to 1 year after enrollment
measure: Compliance statistics for wristband use (Stage II)
timeFrame: Until onset of PDAC, study withdrawal, or death, whichever occurs first, assessed up to 5 years after enrollment
Secondary outcomes:
measure: Compliance statistics for wristband use for all participants (Stage I, II)
timeFrame: Up to 6 weeks and 6 months after enrollment and device activation
measure: Effectiveness of virtual training (Stage I, II)
timeFrame: Up to 1 week after enrollment and device activation
measure: Magnitude of HRV change (Stage II)
timeFrame: Up to 5 years post enrollment
measure: Incidence of PDAC among high-risk participants (Stage II)
timeFrame: Up to 5 years post enrollment
measure: Time of PDAC diagnosis among high-risk participants who developed PDAC (Stage II)
timeFrame: Up to 5 years post enrollment
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone
state: New York
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Aaron Grossberg
role: PRINCIPAL_INVESTIGATOR
References: