Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514, United States
NCT Number: NCT02844400
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.
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Notify Me18 year and older
All sexes
Observational
Chapel Hill, North Carolina, 27514, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 12 months
Measure 1 for study feasibility
Time frame: 12 months
Measure 2 for study feasibility
Time frame: 12 months
Measure 3 for study feasibility
Time frame: 12 months
Measure 4 for study feasibility
Time frame: 12 months
Measure 5 for study feasibility
Time frame: 12 months
Measured via cycle egometry
Time frame: 12 months
Time frame: 12 months
Measured using PROMIS, PRO-CTCAE, Godin Leisure Time Exercise questionnaires and Geriatric Assessment
Time frame: 12 months
Measured using Philips Actiwatch
Time frame: 12 months
Continuous heart rate data, resting heart rate, and heart rate variability will be measured using HealthPatch
Time frame: 12 months
Clinician-rated ECOG and Karnofsky Performance Status (KPS)
Time frame: 12 months
Measured by HealthPatch
Time frame: 12 months
Measured by Philips Actiwatch
UNC Lineberger Comprehensive Cancer Center
Other
Assessing Performance Status in Cancer Patients Using Cardiopulmonary Exercise Testing and Wearable Data Generation: A Prospective Observational Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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