Lung Cancer Exercise Training Study

Lung Cancer Clinical Trial

Official title:

Lung Cancer Exercise Training Study: A Randomized Trial of Aerobic Training, Resistance Training, or Both in Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068210
• Other study ID #: 15-215
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: March 29, 2024

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 29, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Exercise Training
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.
• Progressive Stretching
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Duke University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	17 weeks

External Links

•   Memorial Sloan Kettering Cancer Center