Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial

Lung Cancer Clinical Trial

— ENHANCE  

Official title:

Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06026111
• Other study ID #: 23-247
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Dana-Farber Cancer Institute
• Contact: Dong-Woo Kang, PhD
• Phone: 857-215-2229
• Email: Dong-Woo_Kang[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the feasibility and effects of 12-week exercise training at different intensities among individuals with advanced lung cancer receiving immune checkpoint inhibitors.

The names of the study interventions involved in this study are:

Description:

This single-center, two-armed, pilot randomized controlled research study will assess feasibility and compare immune activities, cardiorespiratory fitness, physical function, and immunotherapy-related adverse events, and patient-reported outcomes between three groups - high-intensity exercise, moderate-intensity exercise, and usual care.

Participants in this study will be randomly assigned to one of three groups:

• High-intensity interval training (HIIT)

• Moderate-intensity continuous training (MICT)

• Usual care (UC) The HIIT and the MICT groups will receive virtually supervised home-based exercise training three sessions per week for 12 weeks. The UC group will be asked not to change their baseline exercise behavior and will be offered to receive one of the exercise programs at the end of the initial 12 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years.

• Histologically diagnosed with advanced non-small cell lung cancer (NSCLC).

• Having been receiving anti-PD-1 or anti-PD-L1 antibodies (i.e., single agent or combination) for at least one month with a plan to continue for at least 12 weeks prospectively at the time of recruitment.

• Medical clearance to perform exercise intervention and testing by their treating oncologist.

• No uncontrolled medical conditions that could be exacerbated with exercise (e.g., uncontrolled hypertension or diabetes).

• Ability to communicate and complete written forms in English.

• Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month.

• Ability to understand and the willingness to sign informed consent prior to any study-related procedures.

• Willing to travel to DFCI for necessary data collection.

Exclusion Criteria:

• Participate in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention outcomes.

• Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because part of this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded.

• Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

• Development of second malignancy (except for basal cell carcinoma or squamous cell carcinoma of the skin) that requires concurrent treatment, which would interfere with this study.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• High-Intensity Interval Training (HIIT)
Home-based, virtually supervised, aerobic exercise intervention at a high intensity in an interval fashion.
• Moderate-Intensity Continuous Training (MICT)
Home-based, virtually supervised, aerobic exercise intervention at a moderate intensity in a continuous fashion.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants completing the exercise intervention sessions	The primary outcome is feasibility and will be assessed by the proportion of enrolled participants completing the exercise intervention sessions with >/=70% completion considered feasible.	Up to 14 weeks
Secondary	Neutrophil-lymphocyte ratio (NLR)	Neutrophil-lymphocyte ratio (NLR) will be assessed as a systemic immune marker as well as a prognostic marker of immunotherapy. Mononuclear lymphocyte phenotypes will be conducted in the Immune Assessment Laboratory. Immunofluorescence assays in whole blood will identify the counts of neutrophils and lymphocytes. Fasting blood will be taken in the morning following an overnight fast. Two 10.0 mL EDTA tubes will be collected and one spun for 10 minutes at 2860rpm within one hour of collection and 1.0mL of plasma will be transferred to a secondary tube to cryovials. Samples will be stored or shipped frozen at -70°C. Samples will be centrifuged, stored at -80°C, and batch-analyzed after post-intervention assessments.	Baseline (Week 1) and post-intervention (Week 14)
Secondary	Cardiopulmonary Fitness	Cardiorespiratory fitness will be assessed as VO2peak by a graded maximal cycle exercise stress test. VO2peak is defined as the highest values of oxygen uptake averaged among every 15-second interval during the test. VO2peak will be reported in both relative (ml·kg-1·min-1) and absolute (L/min) terms.	Baseline (Week 1) and post-intervention (Week 14)
Secondary	Muscular Strength	Muscular strength will be measured as 1-repetition maximum (RM) (i.e., the greatest resistance that can be moved through the full range of motion), which has been the standard for strength assessments. 1-RM values will be estimated from 10-RM using validated equations on 12 exercises including the ten exercises utilized in the prescription not performed on machines.	Baseline (Week 1) and post-intervention (Week 14)
Secondary	Short Physical Performance Battery	Physical function will be assessed by the Short Physical Performance Battery (SPPB), which includes the following 3 lower extremity measures completed in the following order. Timed balance (seconds): Balance will be assessed under 3 conditions (side-by-side, semi-tandem, and tandem stands). Gait speed (seconds): Gait speed will be assessed over a 4-meter flat surface distance. The participant will be asked to complete 2 attempts of this test. Time will be recorded using an electronic timing system. Chair stand (seconds): Chair stand will be performed under 2 conditions: a) subjects will perform a single chair stand; b) subjects will be asked to perform 5 repeated chair stands as quickly as possible; time to completion will be recorded.	Baseline (Week 1) and post-intervention (Week 14)
Secondary	Patient Reported Outcomes - Health-related quality of life	quality of life will be assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ)-C30.	Baseline (Week 1) and post-intervention (Week 14)
Secondary	Patient Reported Outcomes - Lung-cancer related quality of life	Lung-cancer related quality of life will be assessed by the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Lung Cancer (EORTC-QLQ-LC)-29.	Baseline (Week 1) and post-intervention (Week 14)
Secondary	Patient Reported Outcomes - Immunotherapy Symptoms	Immunotherapy symptoms will be assessed by the MD Anderson Symptom Inventory (MDASI) Immunotherapy early-phase trials (EPT).	Baseline (Week 1) and post-intervention (Week 14)
Secondary	Patient Reported Outcomes - Anxiety and Depression	Anxiety and Depression will be assess using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7-item subscales (anxiety and depression). The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence) and the total score is out of 42 (21 per subscale).	Baseline (Week 1) and post-intervention (Week 14)
Secondary	Patient Reported Outcomes - Sleep Quality	Sleep will be assessed using the Pittsburg Sleep Quality Index (PSQI).	Baseline (Week 1) and post-intervention (Week 14)