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NCT04067830 · ClinicalTrials.gov registry record · Phase 2
Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer
A Phase 2 study of Stage IIIB Lung Cancer AJCC v8 and Stage IIIA Lung Cancer AJCC v8, sponsored by Roswell Park Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
- 1
- Study location
NCT04067830: Recruiting Phase 2 study of Stage IIIB Lung Cancer AJCC v8 and Stage IIIA Lung Cancer AJCC v8, sponsored by Roswell Park Cancer Institute.
NCT04067830 is a Phase 2 study of Stage IIIB Lung Cancer AJCC v8 and Stage IIIA Lung Cancer AJCC v8 that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 220 participants, below the 444-participant average among 31 other Stage IIIB Lung Cancer AJCC v8 trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04067830, a Phase 2 study of Stage IIIB Lung Cancer AJCC v8 and Stage IIIA Lung Cancer AJCC v8, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 220 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well respiratory muscle training before surgery works in preventing lung complications after surgery in patients with stage I-IIIB lung cancer. Patients with lung cancer who choose to undergo surgical resection often have complications after surgery such as pneumonia, unplanned intubations, difficulty breathing and reduced physical functioning, and increased medical costs and a reduced quality of life. Improving pre-surgical pulmonary health through respiratory muscle training may improve respiratory muscle strength, response to surgery, and quality of life after surgery in patients with lung cancer.
Primary Outcome
Will be treated as a continuous variable and will be summarized by treatment group and time-point using the mean, median, standard deviation, and the appropriate percentiles. The effectiveness of the respiratory muscle training (RMT) program on each respiratory outcome will be assessed by comparing the preoperative change between groups using an analysis of covariance (ANCOVA) model, with an adjustment for the pretreatment levels. For each outcome, the preoperative change (T1-T0) will be modeled
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- OTHER Best Practice
- PROCEDURE Laparoscopic Surgery
- DEVICE Respiratory Muscle Training Device
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2019-03-20 |
| Est. Completion | 2027-03-22 |
| Phase | Phase 2 |
What NCT04067830 shows while recruiting
NCT04067830 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 444-participant average among 31 other Stage IIIB Lung Cancer AJCC v8 trials with a reported enrollment target (50% lower).
The record links to 10 conditions, with Stage IIIB Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04067830 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04067830 about?
NCT04067830 is a clinical study titled "Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer". This phase II trial studies how well respiratory muscle training before surgery works in preventing lung complications after surgery in patients with stage I-IIIB lung cancer. Patients with lung cancer who choose to undergo surgical resection often have complications after surgery such as pneumonia,...
What is the current status of trial NCT04067830?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2019-03-20. Estimated completion is 2027-03-22.
What conditions does trial NCT04067830 study?
This clinical trial studies the following conditions: Stage IIIB Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage I Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8.
What interventions are being tested in trial NCT04067830?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Best Practice (OTHER), Laparoscopic Surgery (PROCEDURE), Respiratory Muscle Training Device (DEVICE).
Who is sponsoring clinical trial NCT04067830?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04067830 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IIIB Lung Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04067830's enrollment target sits among peer trials
220 9th of 31 higher than 23 of 31 other Stage IIIB Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IIIB Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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