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Trial Title:
Exercise As Maintenance Therapy in Advanced Lung Cancer
NCT ID:
NCT06513663
Condition:
Lung Cancer
Non Small Cell Lung Cancer
Metastatic Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
lung cancer
exercise
non small cell lung cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise Intervention
Description:
Eligible and consented participants randomized to the exercise arm will work with an
exercise trainer three times weekly for 12 weeks. Training sessions will be delivered
virtually using HIPPA Complaint IU Health Zoom. These sessions will last 60 minutes and
include cardiovascular exercise, resistance training, and balance or stretching exercise.
The participants will be able to use any equipment they already have at home but will be
provided a heart monitor and a set of resistance bands.
All sessions will have a moderate-intensity training goal, defined as 40-80% of heart
rate reserve (HRR). Cardiovascular exercise will include any at-home equipment available
to the participants or follow a Tabata-style program. Resistance training will include a
full body workout, emphasizing all major muscle groups. Trainers will progress or regress
intensity levels based on the participant's rate of perceived exertion (RPE), heart rate,
and individual response during each session.
Arm group label:
Exercise Intervention
Summary:
The purpose of this study is to examine how a multimodality (having or using a variety of
methods to do something) exercise intervention may improve survival, function, and
quality of life in participants with advanced lung cancer.
Detailed description:
This study is a randomized control trial at a single institution comparing advanced lung
cancer patients undergoing supervised home-based exercise program versus usual care. The
intervention is a supervised home-based exercise program that will be coordinated by the
MOVE program. The regimen will be 12 weeks in duration, three times a week, and
administered by a trained professional virtually.
Participants will be randomized 1:1 to the exercise or usual care arm. Participants will
be stratified on baseline frailty by the SPPB.
Primary Objective To compare changes patient-reported fatigue (by FACT-F survey) from
baseline to post-intervention in patients with locally advanced and advanced lung cancer
receiving maintenance immunotherapy undergoing a supervised home-based exercise program
versus usual care.
Secondary Objectives
1. To compare changes in cardiorespiratory fitness measured by VO2peak, estimated as
time on the treadmill during ramp treadmill test, from baseline to post-intervention
in patients with locally advanced/advanced lung cancer receiving maintenance
immunotherapy undergoing a supervised home-based exercise program versus usual care.
2. To compare changes in physical function measured by the short physical performance
battery from baseline to post-intervention in patients with locally
advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a
supervised home-based exercise program versus usual care.
3. To compare changes in muscle mass and muscle density measured on CT scans for
disease monitoring and bioimpedance analysis from baseline to post-intervention in
patients with locally advanced/advanced lung cancer receiving maintenance
immunotherapy undergoing a supervised home-based exercise program versus usual care.
4. To compare changes in depression scores by HADS survey from baseline to
post-intervention in patients with locally advanced and/or advanced lung cancer
receiving maintenance immunotherapy undergoing a supervised home-based exercise
program versus usual care.
5. To compare the proportion of patients who are "fatigued," defined as a FACT-F score
of <43 at post-intervention between the exercise and usual care arms.
6. To evaluate uptake and adherence of supervised home-based exercise program in
patients with locally advanced and/or advanced lung cancer receiving maintenance
immunotherapy or targeted therapy, measured by the percentage of patients who
consented to the study and percentage of training sessions attended by patients in
the exercise arm.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Known diagnosis of locally advanced (stage III) or metastatic NSCLC
3. Patient is currently receiving maintenance immunotherapy for at least 1 month and
planned for at least 3 additional months of therapy
1. Patients receiving maintenance therapy refers to patients with stable disease
or partial response to therapy, including patients who have had a history of
disease progression but are currently stable or responding to a different
therapy
2. Patients previously receiving chemotherapy are eligible as long as at least one
month has elapsed since completing chemotherapy. Those currently receiving
chemotherapy are not eligible.
4. Patient is willing and able to participate in a supervised home-based exercise
program as determined by the MOVE program
a.Participants must have internet access and equipment to participate in virtual
exercise
5. ECOG performance status of 0-2
Exclusion Criteria:
1. Already meeting exercise guidelines and participating in at least 150 minutes of
moderate or vigorous exercise per IPAQ
2. Unable to participate in the supervised home-based exercise program as determined by
the MOVE program
3. Medical co-morbidities that preclude patient from participating in supervised
exercise, including but not limited to:
- Advanced heart failure
- Advanced respiratory disease requiring home oxygen use
- Uncontrolled psychiatric disorders
- History of fragility fracture
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Indiana University Health Methodist Hospital
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nada Kassem
Phone:
317-278-5238
Email:
nakassem@iu.edu
Contact backup:
Last name:
Tarah Ballinger, MD
Facility:
Name:
Indiana University Melvin & Bren Simon Comprehensive Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nada Kassem
Phone:
317-278-5238
Email:
nakassem@iu.edu
Contact backup:
Last name:
Tarah Ballinger, MD
Facility:
Name:
Sidney and Lois Eskenazi Hospital
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa Nickol, RN
Email:
lnickol@iu.edu
Contact backup:
Last name:
Tarah Ballinger, MD
Start date:
October 15, 2024
Completion date:
December 2029
Lead sponsor:
Agency:
Indiana University
Agency class:
Other
Source:
Indiana University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06513663
