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Pre-Surgical Respiratory Muscle Training for Lung Cancer

Phase 2

Recruiting

Led By Saikrishna S Yendamuri

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

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

Must have

Participant must be undergoing or is anticipated to either video-assisted thoracic surgery (VATS or robotic surgery) or laparoscopic surgery for curative intent lung resection

Documented stage I-IIIb lung cancer or is undergoing surgery for diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial looks at whether breathing exercises before surgery can help prevent complications afterwards in patients with lung cancer.

Who is the study for?

This trial is for patients with stage I-IIIB lung cancer, who can understand English and are set to have curative surgery (VATS or laparoscopic). It includes those who've had chemoradiotherapy. Excluded are pregnant women, those too frail, with poor performance status (ECOG > 2), or serious heart issues.Check my eligibility

What is being tested?

The study tests if training the respiratory muscles before surgery can prevent complications like pneumonia and breathing problems after lung cancer surgery. It involves exercises using a device, quality-of-life assessments, and questionnaires.See study design

What are the potential side effects?

Since this trial focuses on pre-surgical muscle training rather than medication, side effects may be minimal but could include muscle fatigue or discomfort from the use of the training device.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for or considering minimally invasive surgery for lung cancer.

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My lung cancer is between stage I and IIIb, or I am having surgery to diagnose it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in inspiratory and expiratory muscle strength

Change in peak exercise capacity (VO2peak)

Change in pulmonary function and respiratory muscle endurance

Secondary outcome measures

Change in QoL

Anxiety

Change in dyspnea

+7 more

Other outcome measures

Identified molecular marker analysis

Lung infection rates

Pre-operative LOS

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (RMT + usual care)Experimental Treatment6 Interventions

Patients use a power lung device to complete 3 sets of 15 RMT exercises over 30 minutes 6 days per week over 2-4 weeks for a minimum of 12 sessions prior to surgery. Patients also receive usual care consisting of attending physical therapy once weekly, receiving pre-surgical information, instruction on the use of a spirometer device, and wearing a Fitbit to track activity. Patients then undergo video-assisted thoracic surgery or laparoscopic surgery. Patients continue to track activity using the Fitbit for 3 months post-surgery.

Group II: Arm I (usual care)Active Control5 Interventions

Patients receive usual care consisting of physical therapy once weekly, receiving pre-surgical information, instruction on the use of a spirometer device, and wearing a Fitbit to track activity. Patients then undergo video-assisted thoracic surgery or laparoscopic surgery. Patients continue to track activity using the Fitbit for 3 months post-surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Laparoscopic Surgery

1996

Completed Phase 4

~126000

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,638 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,269 Total Patients Enrolled

Saikrishna S YendamuriPrincipal InvestigatorRoswell Park Cancer Institute

1 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Video-Assisted Thoracic Surgery Clinical Trial Eligibility Overview. Trial Name: NCT04067830 — Phase 2

Lung Cancer Research Study Groups: Arm I (usual care), Arm II (RMT + usual care)

Lung Cancer Clinical Trial 2023: Video-Assisted Thoracic Surgery Highlights & Side Effects. Trial Name: NCT04067830 — Phase 2

Video-Assisted Thoracic Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT04067830 — Phase 2

Frequently Asked Questions

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

Is the recruitment process underway for this experiment?

"Affirmative. Clinicaltrials.gov houses the details indicating that this trial is recruiting, having been published on March 20th 2019 and edited most recently on November 15th 2022. It requires 220 participants from a single medical centre to enroll in it."

Answered by AI

To what extent is Video-Assisted Thoracic Surgery a hazard to patients?

"Video-Assisted Thoracic Surgery is deemed to be a moderately safe procedure, scoring a 2 on our safety scale. Although Phase 2 data supports its security, there are currently no studies that suggest its efficacy."

Answered by AI

What outcome are researchers hoping to achieve with this medical experiment?

"This trial's primary metric for assessment spans from the baseline to 12 months, with an aim to evaluate changes in inspiratory and expiratory muscle strength. Secondary objectives include measuring any alterations in anxiety and depression via Hospital Anxiety and Depression Scale, dyspnea through Borg Dyspnea Scale, as well as fatigue levels using Functional Assessment of Chronic Illness Therapy Fatigue. As these are continuous measures that will be parsed by treatment group and time-point, a general linear model along with Holm-Bonferroni adjusted tests will be employed while verifying assumptions graphically utilizing quantile-quantile plots and residuals."

Answered by AI

How many participants have been identified for this clinical trial?

"Affirmative. Clinicaltrials.gov records indicate that this experiment, which was first advertised on March 20th 2019, is actively recruiting participants. 220 individuals must be enrolled from 1 site for the trial to proceed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer

2019. "Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04067830.