A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation (REM)

Stopped early · Not applicable

Conditions studied: Lung Cancer

In brief

The purpose of this study is to conduct a pilot randomized controlled trial (RCT) evaluating the feasibility and potential effectiveness of a remotely supervised exercise program (REM) in promoting adherence to an exercise prescription before and during chemoradiation.

Key facts

Study ID

NCT03500393

Run by

Dartmouth-Hitchcock Medical Center

People needed

4

Starts

2018-06-22

Expected to finish

2021-01-23

Last updated by the study team

2021-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are over the age of 18 and diagnosed with Stage IIa to IIIb lung cancer;
• Definitive treatment with chemoradiation with weekly carboplatin and paclitaxel concurrent with radiation is planned to begin in no less than 2 weeks;
• Have an Apple or Android device with capacity to install a fitness device app and access to either WiFi or cellular service;
• Are English-speaking and able to provide voluntary, written consent;
• Able to tolerate chemoradiation as indicated by Zubrod/ECOG Performance Status 0-1; CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl;Adequate renal function within 14 days prior to registration, defined as creatinine clearance must be at least 35 ml/min; Adequate hepatic function within 14 days prior to registration, defined as total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution and ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution; No prior thoracic radiation therapy;

You may not qualify if…

• Life expectancy of < 12 months or are receiving hospice services;
• Psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideation;
• Exhibit American College of Sports Medicine contraindications to exercise which include a resting heart rate of >120bpm, blood pressure >180/100mmHg or unstable angina 40 or musculoskeletal issue preventing exercise;
• Are unable to walk 100 meters. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe;
• Less than 2 weeks to the beginning of chemoradiation;
• Physician discretion;
• Are unable to walk or to complete the 6-minute walk test. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe.

Where it is running

• Dartmouth Hitchcock Medical Center — Hanover, New Hampshire, United States

Full record on ClinicalTrials.gov

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