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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02844400
Other study ID # LCCC 1605
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2016
Est. completion date December 2018

Study information

Verified date February 2019
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this study is to establish the feasibility and value of physical fitness assessment within patients receiving cytotoxic chemotherapy. If successful, this project will establish the groundwork for physical function assessment in larger cancer clinical trials to assist patient selection and evaluation of toxicity and/or response among trial participants.


Description:

Physical fitness, whether measured by performance capacity or daily activity, can predict risk of toxicity while helping to evaluate toxicity itself in the course of cancer chemotherapy. Cytotoxic chemotherapy causes premature aging and frailty in many cancer patients, so measuring and improving physical function may also limit late morbidity and mortality. Clinician-rated performance status (cPS; e.g., ECOG or Karnofsky PS) with or without concomitant organ function testing is the usual gold standard for risk prognostication and patient selection in most cancer settings, but cPS is subjective, unreliable, and relatively sensitive only for patients with significant functional compromise. Objective evaluations of physical function have the potential to augment or even replace cPS in the cancer treatment setting.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients receiving cytotoxic chemotherapy with at least a 3 week cycle (either adjuvant/curative or palliative)

- Age = 18, prioritizing patients = 60 years

- At least 6 weeks out from surgical resection

- Presence of working email address

- Access to internet at home and either access to wireless internet or cellular data reception

- Ability to read and understand English

- Ability to understand and comply with study procedures

Exclusion Criteria:

- Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent

- Contraindication to CPET per standard American Thoracic Society (ATS) guidelines

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Biometric Devices
Patients will wear two devices: HealthPatch Sensor and Phillips Actiwatch. Health data (e.g. average steps per day, resting heart rate) will be collected and monitored over the course of a cycle of cytotoxic chemotherapy.
Other:
Physical Performance Testing
Patients will complete a CPET and 6 minute walk test within one week of starting an upcoming chemotherapy cycle and they will undergo a second CPET upon completion of said chemotherapy cycle.

Locations

Country Name City State
United States Lineberger Comprehensive Cancer Center Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients being approached that agree to participate in the study Measure 1 for study feasibility 12 months
Primary Proportion of patients who complete both baseline and follow up CPET tests without significant testing-related adverse events Measure 2 for study feasibility 12 months
Primary Proportion of patients who wear HealthPatch and have data captured successfully for at least 75% of the time Measure 3 for study feasibility 12 months
Primary Patients who wear Philips Actiwatch and have data captured successfully for at least 75% of the time Measure 4 for study feasibility 12 months
Primary Proportion of patients for whom all data is successfully recorded within the database Measure 5 for study feasibility 12 months
Secondary VO2max measured both pre- and post-chemotherapy Measured via cycle egometry 12 months
Secondary 6 Minute Walk Distance (6MWD) 12 months
Secondary Patient-reported sympotomatic toxicity and quality of life Measured using PROMIS, PRO-CTCAE, Godin Leisure Time Exercise questionnaires and Geriatric Assessment 12 months
Secondary Patient activity/steps per day Measured using Philips Actiwatch 12 months
Secondary Heart rate Continuous heart rate data, resting heart rate, and heart rate variability will be measured using HealthPatch 12 months
Secondary Clinician-rated performance status Clinician-rated ECOG and Karnofsky Performance Status (KPS) 12 months
Secondary Incidence and number of falls Measured by HealthPatch 12 months
Secondary Sleep duration Measured by Philips Actiwatch 12 months
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