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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 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

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
13,660 Previous Clinical Trials
40,924,070 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
~34 spots leftby Mar 2025