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CPAP or Deep Inspiration Breath Hold for Lung Cancer

Phase 1 & 2
Waitlist Available
Led By Julianne M Pollard
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient has a biopsy-proven radio-opaque (visible by computed tomography [CT]) lung cancer or secondary metastasis to the lung.
The patient will receive thoracic stereotactic body radiotherapy at MD Anderson.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 days
Awards & highlights

Study Summary

This trial is testing two methods to see which is better at reducing tumor movement during radiation therapy for lung cancer.

Who is the study for?
This trial is for lung cancer patients who will receive thoracic SBRT at MD Anderson and have a CT-visible tumor. It's not for those with reduced consciousness, contraindications to CPAP use, no consent given, uncooperative behavior, recent facial or upper body surgery, or idiopathic pulmonary fibrosis.Check my eligibility
What is being tested?
The study compares the effectiveness of a CPAP device versus deep inspiration breath hold in reducing tumor movement during lung cancer treatment with SBRT. The goal is to see if CPAP can better restrict tumor motion than the standard breath-holding technique.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing a face mask or nozzle (for CPAP), difficulty breathing due to air pressure changes, and possible anxiety or claustrophobia during breath holding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
Select...
My lung cancer or its spread to the lung is visible on a CT scan.
Select...
I will get a specific type of radiation therapy at MD Anderson.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Estimation of decrease in tumor motion
Secondary outcome measures
Assessment of time to deliver the planned radiation dose by using the most appropriate method
Increase in lung volume

Side effects data

From 2014 Phase 2 trial β€’ 53 Patients β€’ NCT01187771
32%
Respiratory tract infections
21%
Drowsy driving
18%
Injuries NEC
14%
Aural disorders NEC
14%
Epidermal and dermal conditions
11%
Gastrointestinal signs and symptoms
11%
Joint disorders
7%
Upper respiratory tract disorders (excl infections)
7%
Headaches
7%
Gallbladder disorders
7%
Tendon, ligament and cartilage disorders
7%
Female reproductive tract infections and inflammations
7%
Respiratory disorders NEC
4%
Anxiety disorders and symptoms
4%
Suicidal and self-injurious behaviors NEC
4%
Gastrointestinal infections
4%
Gastrointestinal motility
4%
Procedural related injuries and complicatins NEC
4%
Glucose metabolism disorders
4%
Genitourinary tract disorders NEC
4%
Medication errors
4%
Bone disorders (excl congenital and fractures)
4%
Ocular infections, irritations and inflammations
4%
Diverticular disorders
4%
Bone and joint injuries
4%
Muscle disorders
4%
Musculoskeletal and connective tissue disorders NEC
4%
Coronary artery disrders
4%
Urinary tract signs and symptoms
4%
Demyelinating disorders
4%
Depressed mood disorders and disturbances
4%
Mood disorders and disturbances NEC
4%
Skin and subcutaneous tissue infections and infestations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Laparoscopic Gastric Banding
Continuous Positive Airway Pressure

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)Experimental Treatment6 Interventions
Patients undergo free-breathing, DIBH, and CPAP CT simulation scans. If patient has difficulty exhaling on CPAP, then patient undergo BiPAP CT simulation. The attending physician then compares all 3 simulation treatment plans (free-breathing, DIBH, and CPAP/BiPAP) and determines which method to use during SBRT. If CPAP/BiPAP is chosen as preferred method, patients wear CPAP/BiPAP over 1 hour prior to SBRT, then again during SBRT over 30-60 minutes. All other patients complete free-breathing or DIBH during SBRT over 30-60 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy Treatment Planning and Simulation
2014
N/A
~10
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Computed Tomography
2017
Completed Phase 2
~2790
Continuous Positive Airway Pressure
2016
Completed Phase 3
~1680

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,434 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,631 Total Patients Enrolled
Julianne M PollardPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Stereotactic Body Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03422302 β€” Phase 1 & 2
Lung Cancer Research Study Groups: Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)
Lung Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT03422302 β€” Phase 1 & 2
Stereotactic Body Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03422302 β€” Phase 1 & 2

Frequently Asked Questions

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

Are recruitment efforts ongoing for this experiment?

"Affirmative. According to information found on clinicaltrials.gov, this medical trial is actively searching for suitable participants and was initially posted on March 16th 2018 with the latest edit being made September 22nd 2022. 30 individuals are needed from a single location."

Answered by AI

How many participants are being recruited for this clinical research?

"Affirmative. Based on the data hosted at clinicaltrials.gov, this medical trial is currently seeking to recruit participants - with a total of 30 patients from 1 site being accepted since its initial posting on March 16th 2018 and subsequent editing on September 22nd 2022."

Answered by AI
~6 spots leftby May 2028