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Behavioral Intervention

Exercise for Lung Cancer (INHALE Trial)

N/A

Recruiting

Led By Christina Dieli-Conwright, MPH, 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).

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

INHALE Trial Summary

This trial studies if a 12-week home workout program, supervised virtually, can improve health for those with advanced lung cancer receiving immunotherapy.

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.Check my eligibility

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.See study design

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.

INHALE Trial 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.

INHALE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of Participants completing the exercise intervention sessions

Secondary outcome measures

Cardiopulmonary Fitness

Muscular Strength

Neutrophil-lymphocyte ratio (NLR)

+6 more

INHALE Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group B: Moderate-Intensity Continuous TrainingExperimental Treatment1 Intervention

10 Participants will complete study procedures as follows: Baseline clinic visit with assessments. 36 virtual sessions of exercise intervention, 3 x weekly. Post-intervention clinic visit with assessments.

Group II: Group A: High-Intensity Interval TrainingExperimental Treatment1 Intervention

Group III: Group C: Usual CareActive Control1 Intervention

10 Participants will complete study procedures as follows: Post-intervention clinic visit with assessments. 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

2019

N/A

~570

Moderate-Intensity Continuous Training

2022

N/A

~140

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,950 Total Patients Enrolled

Christina Dieli-Conwright, MPH, PhDPrincipal InvestigatorDana-Farber Cancer Institute

1 Previous Clinical Trials

84 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor still need participants?

"As outlined on the clinicaltrials.gov website, this trial is not presently enrolling patients. It was initially posted in January 1st 2024 and modified August 30th 2023. That said, there are 1508 other medical studies currently recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility and Preliminary Efficacy of Exercise During Immunotherapy in Patients With Lung Cancer: The INHALE Trial

Christina Dieli-Conwright, PhD 2023. "Feasibility and Preliminary Efficacy of Exercise During Immunotherapy in Patients With Lung Cancer: The INHALE Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06026111.