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Lung Cancer Exercise Training Study

Primary Purpose

Lung Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Training
Progressive Stretching
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Exercise Intervention, Lung Cancer, 15-215

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent prior to initiation of study-related procedures
  • Age 21 - 80 years
  • Weight < 205 kgs
  • ECOG ≤ 1
  • Diagnosed with histologically confirmed lung cancer, regardless of disease stage and receiving any prior line of any therapy in the context of metastatic disease
  • An interval of at least three months following the completion of primary resection, if appropriate
  • An interval of no longer than ten years following completion of primary therapy, if appropriate
  • Life expectancy ≥ 4 months
  • Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week
  • Exercise intolerance (i.e., patients must have a VO2peak below that predicted for active age and sex-matched individuals)
  • Willing to be randomized to one of the study arms
  • Willing to commit to the study program and comply with all related protocol procedures
  • Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:

    • achieving a plateau in oxygen consumption, concurrent with an increase in power output;
    • a respiratory exchange ratio ≥ 1.10;
    • attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]);
    • volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
  • Able to complete an acceptable baseline CPET in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the PI.
  • Ability to achieve and complete an acceptable baseline one-repetition maximum muscular strength test as defined by the effective execution of protocol-specific joint and muscle ranges of motion without remarkable signs or symptoms of pain, discomfort or distress.

Exclusion Criteria:

  • Presence of a concurrent, actively treated other malignancy, or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer);
  • Room air desaturation at rest ≤ 85%;
  • Mental impairment leading to inability to cooperate.
  • Any of the following absolute contraindications to cardiopulmonary exercise testing:

    • Acute myocardial infarction (within 3-5 days of any planned study procedures);
    • Unstable angina;
    • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
    • Recurrent syncope;
    • Active endocarditis;
    • Acute myocarditis or pericarditis;
    • Symptomatic severe aortic stenosis;
    • Uncontrolled heart failure;
    • Acute (within 3 months) pulmonary embolus or pulmonary infarction;
    • Thrombosis of lower extremities;
    • Suspected dissecting aneurysm;
    • Uncontrolled asthma;
    • Pulmonary edema;
    • Respiratory failure;
    • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis); or

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Aerobic Training

Resistance Training

Combined Aerobic and Resistance Training

Progressive Stretching Group (Attention-Control)

Arm Description

A customized and supervised endurance exercise training program that will last 4 months (16 weeks). The regimen will be tailored to the individual fitness level. The exercise program will consist of three supervised sessions per week. During each session, the participant will cycle on a stationary bicycle at moderate intensity for approximately 30-60 minutes.

A customized and supervised resistance exercise training program that will last 4 months (16 weeks). Resistance training will be performed on stationary weight machines, modification in equipment may be made by Exercise Physiologist. Patients will be progressively trained to perform two to three sets of 75-85% of maximal strength The participant will be trained to perform different resistance exercise, alternating between lower and upper body muscle groups. The exercise program will consist of three supervised sessions per week. Each session will last approximately 30-60 minutes.

A customized and supervised endurance exercise training program that will last 4 months (16 weeks). The regimen will be tailored to the individual fitness level, and will be a combination of Arm A and Arm B, described above. At each session, the participant will complete aerobic training on a stationary bicycle and also resistance training using stationary weight machines. The exercise program will consist of three supervised sessions per week. Each session will last approximately 30-90 minutes.

A customized and supervised progressive stretching program that will last 4 months (16 weeks). The progressive stretching program will consist of a series of stretching exercises alternating between lower and upper body muscle groups/joints. This program will consist of three exercise sessions a week. Each session will last approximately 30-60 minutes.

Outcomes

Primary Outcome Measures

changes in VO2peak (on exercise capacity)
by comparing the efficacy of different types of exercise training modalities in lung cancer following the completion of primary adjuvant therapy.

Secondary Outcome Measures

Full Information

First Posted
February 11, 2010
Last Updated
October 18, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT01068210
Brief Title
Lung Cancer Exercise Training Study
Official Title
Lung Cancer Exercise Training Study: A Randomized Trial of Aerobic Training, Resistance Training, or Both in Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), Duke University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is look at the effects of different types of exercise training with a stretching group and its effect on lung cancer patients. Subjects will take part in a 16 week training intervention that can consist of aerobic, resistance, aerobic & resistance, or a control group. Pre and Post testing will include stress tests, echos, blood, and urine samples.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Exercise Intervention, Lung Cancer, 15-215

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Training
Arm Type
Experimental
Arm Description
A customized and supervised endurance exercise training program that will last 4 months (16 weeks). The regimen will be tailored to the individual fitness level. The exercise program will consist of three supervised sessions per week. During each session, the participant will cycle on a stationary bicycle at moderate intensity for approximately 30-60 minutes.
Arm Title
Resistance Training
Arm Type
Experimental
Arm Description
A customized and supervised resistance exercise training program that will last 4 months (16 weeks). Resistance training will be performed on stationary weight machines, modification in equipment may be made by Exercise Physiologist. Patients will be progressively trained to perform two to three sets of 75-85% of maximal strength The participant will be trained to perform different resistance exercise, alternating between lower and upper body muscle groups. The exercise program will consist of three supervised sessions per week. Each session will last approximately 30-60 minutes.
Arm Title
Combined Aerobic and Resistance Training
Arm Type
Experimental
Arm Description
A customized and supervised endurance exercise training program that will last 4 months (16 weeks). The regimen will be tailored to the individual fitness level, and will be a combination of Arm A and Arm B, described above. At each session, the participant will complete aerobic training on a stationary bicycle and also resistance training using stationary weight machines. The exercise program will consist of three supervised sessions per week. Each session will last approximately 30-90 minutes.
Arm Title
Progressive Stretching Group (Attention-Control)
Arm Type
Active Comparator
Arm Description
A customized and supervised progressive stretching program that will last 4 months (16 weeks). The progressive stretching program will consist of a series of stretching exercises alternating between lower and upper body muscle groups/joints. This program will consist of three exercise sessions a week. Each session will last approximately 30-60 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Training
Intervention Description
The overall goal for all the exercise training groups will be 3 supervised exercise sessions per week an intensity between 50 to 100% of the individually determined VO2peak for aerobic training and an intensity between 50% to 85% of 1-RM for resistance training. All the exercise interventions are designed such that participants begin exercising at a low intensity (~50%-60% VO2peak / 1RM) that is subsequently increased to more moderate to vigorous intensity (~70%-100% VO2peak / ~70-85% 1RM) when appropriate. All interventions will be individually tailored to each patient following the principles of aerobic or resistance training prescription guidelines for adults.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Stretching
Intervention Description
The ultimate goal for the progressive stretching program is 3 individual stretching sessions. All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
Primary Outcome Measure Information:
Title
changes in VO2peak (on exercise capacity)
Description
by comparing the efficacy of different types of exercise training modalities in lung cancer following the completion of primary adjuvant therapy.
Time Frame
17 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent prior to initiation of study-related procedures Age 21 - 80 years Weight < 205 kgs ECOG ≤ 1 Diagnosed with histologically confirmed lung cancer, regardless of disease stage and receiving any prior line of any therapy in the context of metastatic disease An interval of at least three months following the completion of primary resection, if appropriate An interval of no longer than ten years following completion of primary therapy, if appropriate Life expectancy ≥ 4 months Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week Exercise intolerance (i.e., patients must have a VO2peak below that predicted for active age and sex-matched individuals) Willing to be randomized to one of the study arms Willing to commit to the study program and comply with all related protocol procedures Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria: achieving a plateau in oxygen consumption, concurrent with an increase in power output; a respiratory exchange ratio ≥ 1.10; attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]); volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale. Able to complete an acceptable baseline CPET in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the PI. Ability to achieve and complete an acceptable baseline one-repetition maximum muscular strength test as defined by the effective execution of protocol-specific joint and muscle ranges of motion without remarkable signs or symptoms of pain, discomfort or distress. Exclusion Criteria: Presence of a concurrent, actively treated other malignancy, or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer); Room air desaturation at rest ≤ 85%; Mental impairment leading to inability to cooperate. Any of the following absolute contraindications to cardiopulmonary exercise testing: Acute myocardial infarction (within 3-5 days of any planned study procedures); Unstable angina; Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; Recurrent syncope; Active endocarditis; Acute myocarditis or pericarditis; Symptomatic severe aortic stenosis; Uncontrolled heart failure; Acute (within 3 months) pulmonary embolus or pulmonary infarction; Thrombosis of lower extremities; Suspected dissecting aneurysm; Uncontrolled asthma; Pulmonary edema; Respiratory failure; Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis); or
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34658160
Citation
Scott JM, Thomas SM, Herndon JE 2nd, Douglas PS, Yu AF, Rusch V, Huang J, Capaci C, Harrison JN, Stoeckel KJ, Nilsen T, Edvardsen E, Michalski MG, Eves ND, Jones LW. Effects and tolerability of exercise therapy modality on cardiorespiratory fitness in lung cancer: a randomized controlled trial. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1456-1465. doi: 10.1002/jcsm.12828. Epub 2021 Oct 17.
Results Reference
derived
Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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Lung Cancer Exercise Training Study

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