Clinical trial NCT01068210: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Exercise Intervention
Lung Cancer
15-215
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Duke University
First posted: 2010-02-12
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Changes in VO2peak (on Exercise Capacity)
timeFrame: 17 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Lee Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.