What side effects are associated with this type of intervention?

Common treatments for lung cancer, such as chemotherapy, radiotherapy, and targeted therapy, often result in side effects like fatigue, dyspnea (shortness of breath), and reduced exercise capacity. Exercise interventions, including high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT), have been studied for their potential to improve physical fitness and health outcomes in lung cancer patients. These exercise programs can help mitigate some of the treatment-related side effects by improving cardiorespiratory fitness, muscular strength, and reducing fatigue. However, it is important to approach exercise cautiously, especially in patients with significant fatigue or other severe symptoms, to avoid exacerbating their condition.

What prior FDA approvals exist?

While the FDA has approved various drugs for the treatment of lung cancer, such as targeted therapies and immunotherapies, there is limited information on approvals specifically related to exercise interventions like High-intensity interval training (HIIT) and Moderate-intensity continuous training (MICT). However, exercise programs are increasingly being studied for their potential to improve physical fitness and health outcomes in lung cancer patients. These interventions aim to enhance endurance, reduce fatigue, and improve overall quality of life, complementing traditional medical treatments.

What other types of research exist?

Promising novel alternatives to HIIT and MICT for lung cancer patients include: 1) Progressive aerobic and strength training rehabilitation programs that start with breathing exercises, gentle stretching, and light muscle strengthening before introducing targeted cardiovascular exercises. 2) Structured and supervised exercise programs that are cautiously initiated and gradually increased in intensity, with close monitoring of vital signs. 3) Integrative therapies such as mind-body practices (e.g., yoga, tai chi) that can help manage symptoms and improve quality of life. 4) Nutritional support programs to address muscle mass loss and overall nutritional status.

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Behavioral Intervention

Exercise for Lung Cancer (ENHANCE Trial)

N/A

Recruiting

Led By Dong-Woo Kang, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically diagnosed with metastatic Non-small cell lung cancer (NSCLC).

Not receiving other concurrent systemic treatment (e.g., chemotherapy or targeted therapy).

Must not have

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.

Receiving other concurrent systemic treatment for NSCLC such as chemotherapy or targeted therapy. This study is to exclusively target patients receiving anti-PD-1/PD-L-1 where other treatments may impact the study outcomes of intervention feasibility and efficacies.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 1) and post-intervention (week 14)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two types of exercise programs for people with advanced lung cancer who are receiving a specific cancer treatment. One program involves short bursts of intense exercise, while the other involves steady, moderate exercise. The goal is to see if these exercises can improve health and reduce side effects from their treatment.

Who is the study for?

The INHALE Trial is for adults over 18 with advanced lung cancer who are on single-agent anti-PD-1 or anti-PD-L1 immunotherapy and can exercise safely. They should do less than 60 minutes of moderate-to-vigorous exercise weekly, not be on other systemic treatments like chemo, and must understand English.

What is being tested?

This study tests if a home-based, virtually supervised 12-week exercise program is workable and beneficial for lung cancer patients on immunotherapy. It compares high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), and usual care.

What are the potential side effects?

Since the interventions involve different intensities of physical activity, potential side effects may include muscle soreness, fatigue, or injury related to exercise. The trial aims to ensure these activities are safe for participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with metastatic non-small cell lung cancer.

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I am not currently on any other cancer treatments.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have another cancer that needs treatment at the same time as this study.

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I am not on any other systemic treatments for NSCLC besides anti-PD-1/PD-L1.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 1) and post-intervention (week 14)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 1) and post-intervention (week 14)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 1) and post-intervention (week 14) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Participants completing the exercise intervention sessions

Secondary study objectives

Cardiopulmonary Fitness

Muscular Strength

Neutrophil-lymphocyte ratio (NLR)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Moderate-Intensity Continuous Training (MICT)Experimental Treatment1 Intervention

The MICT group will perform an aerobic exercise at a continuous intensity in each session on a stationary bike. Similar to HIIT, the intensity will be progressed (47.5-60%). The total work of MICT is equalized with HIIT for training volume and frequency to compare the differences exerted from different intensities and energy expenditure.

Group II: High-Intensity Interval Training (HIIT)Experimental Treatment1 Intervention

Patients in the HIIT group will perform alternating vigorous-intensity and recovery aerobic exercise intervals on a provided home stationary bike. The HIIT protocol consists of alternating a high-intensity exercise phase (1 min at 65-90% of workload corresponding to VO2peak) and a recovery phase (1 min at 30%), and the high-intensity and recovery intervals will be repeated 5-10 times in each session.

Group III: Usual Care (UC)Active Control1 Intervention

Participants will be asked to maintain their baseline exercise behavior and will be offered to participate in the HIIT exercise program upon the completion of post-intervention assessments after the initial 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High-Intensity Interval Training (HIIT)

2021

N/A

~230

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lung cancer include surgery, chemotherapy, radiation therapy, and targeted therapies. Surgery involves physically removing the tumor, which is crucial for localized cancers. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while radiation therapy uses high-energy rays to destroy cancer cells' DNA. Targeted therapies focus on specific molecular targets associated with cancer growth. These treatments are essential for controlling and potentially curing lung cancer. Exercise interventions like HIIT and MICT, although not direct treatments, can improve physical fitness, enhance recovery, and potentially improve overall health outcomes for lung cancer patients by increasing exercise capacity and respiratory muscle strength.

Combined aerobic exercise and high-intensity respiratory muscle training in patients surgically treated for non-small cell lung cancer: a pilot randomized clinical trial.