Continuous Positive Airway Pressure (CPAP) Device to Reduce Tumor Motion in Stereotactic Body Radiotherapy (SBRT) Lung Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 16, 2018 |
| End Date: | March 2020 |
| Contact: | Julianne M. Pollard, PHD |
| Email: | CR_Study_Registration@mdanderson.org |
| Phone: | 713-563-2591 |
Measuring the Effectiveness of a Continuous Positive Airway Pressure (CPAP) Device to Reduce Tumor Motion and Increase Lung Volume Expansion in Patients Undergoing Stereotactic Body Radiotherapy (SBRT) for Tumors That Move With Respiration
When receiving stereotactic body radiotherapy (SBRT), it is important that you do not move so
the radiation therapy can be delivered to the tumor. For patients with tumors in their chest,
it is very hard to keep the area still because breathing may cause the tumor to move.
The goal of this clinical research study is to compare 2 different methods of lowering the
amount of tumor movement in patients who are receiving SBRT. In this study, a breath-holding
technique (the standard method) and a device called continuous positive airway pressure
(CPAP) will be compared. The CPAP device blows air into your lungs while you wear a face mask
or nozzle to help expand your airways and lungs.
This is an investigational study. The CPAP device is FDA-approved and commercially available
for expanding the airways. It is considered investigational to use it to lower the amount of
tumor movement during SBRT therapy.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
the radiation therapy can be delivered to the tumor. For patients with tumors in their chest,
it is very hard to keep the area still because breathing may cause the tumor to move.
The goal of this clinical research study is to compare 2 different methods of lowering the
amount of tumor movement in patients who are receiving SBRT. In this study, a breath-holding
technique (the standard method) and a device called continuous positive airway pressure
(CPAP) will be compared. The CPAP device blows air into your lungs while you wear a face mask
or nozzle to help expand your airways and lungs.
This is an investigational study. The CPAP device is FDA-approved and commercially available
for expanding the airways. It is considered investigational to use it to lower the amount of
tumor movement during SBRT therapy.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
Simulation Scans:
If you agree to take part in this study, before you receive SBRT therapy, you will come to
the clinic for a simulation scan visit. During this visit, you will have CT scans while
breathing normally, next, you will take CT scans while using the breath-holding technique. It
may take about 1 - 1.5 hours to complete. You will not receive any SBRT therapy on this day.
First, you will have a CT scan to check how much your tumor moves while you breathe normally.
For the breath hold scans, you will hold your breath for about 15 seconds (or as long as you
can comfortably hold it). The study staff will tell you when to begin holding your breath and
when to stop. If you need to breathe before the study staff tells you to begin breathing
again, you may do so.
Following that simulation, you will be sent to our Sleep Center where they will evaluate you
for using a CPAP device. They will determine if you are suitable for the device and fit you
for a mask. You will be fitted with the CPAP device and shown how to use the device. This
should take less than 1 hour. The main goal is to familiarize you with the CPAP. You will be
scheduled for your final CT simulation while using CPAP 2-3 days later.
At this simulation, you will work with the study staff to find a comfortable setting for the
amount of air blown into your lungs. This may take up to 1 hour. Members of the MD Anderson
Sleep Center will also be there to help with this process.
If you are benefitting from the CPAP machine, you may be referred to a sleep center to
continue using the machine.
After the device has been fitted and a comfortable setting has been found, you will wear the
device for about 1 hour to get used to the machine. After the 1 hour has passed, you will
have another set of CT scans performed while wearing the CPAP device.
SBRT Treatment:
On your first day of SBRT, you will return to the clinic to receive your SBRT therapy. Based
on the CT scan results, the doctor will decide if you will use the breath-holding method or
the CPAP device during your SBRT therapy. You may not need either of these methods. This will
be up to the study doctor.
If the doctor thinks the CPAP device is best for you, an additional 45 minutes to 1 hour will
be added your SBRT therapy day. This is because you must sit for a period of time while
wearing the CPAP device before receiving therapy. The actual SBRT treatment only will take 30
minutes to 1 hour for each day of treatment. Typical SBRT cases require 4-10 days of
treatment.
Length of Study Participation:
Your participation in this study will be over after you receive one (1) round of SBRT therapy
using one of the methods above.
If you agree to take part in this study, before you receive SBRT therapy, you will come to
the clinic for a simulation scan visit. During this visit, you will have CT scans while
breathing normally, next, you will take CT scans while using the breath-holding technique. It
may take about 1 - 1.5 hours to complete. You will not receive any SBRT therapy on this day.
First, you will have a CT scan to check how much your tumor moves while you breathe normally.
For the breath hold scans, you will hold your breath for about 15 seconds (or as long as you
can comfortably hold it). The study staff will tell you when to begin holding your breath and
when to stop. If you need to breathe before the study staff tells you to begin breathing
again, you may do so.
Following that simulation, you will be sent to our Sleep Center where they will evaluate you
for using a CPAP device. They will determine if you are suitable for the device and fit you
for a mask. You will be fitted with the CPAP device and shown how to use the device. This
should take less than 1 hour. The main goal is to familiarize you with the CPAP. You will be
scheduled for your final CT simulation while using CPAP 2-3 days later.
At this simulation, you will work with the study staff to find a comfortable setting for the
amount of air blown into your lungs. This may take up to 1 hour. Members of the MD Anderson
Sleep Center will also be there to help with this process.
If you are benefitting from the CPAP machine, you may be referred to a sleep center to
continue using the machine.
After the device has been fitted and a comfortable setting has been found, you will wear the
device for about 1 hour to get used to the machine. After the 1 hour has passed, you will
have another set of CT scans performed while wearing the CPAP device.
SBRT Treatment:
On your first day of SBRT, you will return to the clinic to receive your SBRT therapy. Based
on the CT scan results, the doctor will decide if you will use the breath-holding method or
the CPAP device during your SBRT therapy. You may not need either of these methods. This will
be up to the study doctor.
If the doctor thinks the CPAP device is best for you, an additional 45 minutes to 1 hour will
be added your SBRT therapy day. This is because you must sit for a period of time while
wearing the CPAP device before receiving therapy. The actual SBRT treatment only will take 30
minutes to 1 hour for each day of treatment. Typical SBRT cases require 4-10 days of
treatment.
Length of Study Participation:
Your participation in this study will be over after you receive one (1) round of SBRT therapy
using one of the methods above.
Inclusion Criteria:
1. The patient has a biopsy-proven radio-opaque (visible by CT) lung cancer or secondary
metastasis to the lung.
2. The patient will receive thoracic stereotactic body radiotherapy at MD Anderson.
Exclusion Criteria:
1. The patient has a contra-indication for using a CPAP device.
2. The patient has not signed a study-specific informed consent for this study.
3. The patient is uncooperative.
4. The patient has reduced consciousness.
5. The patient has sustained trauma or burns to the face.
6. The patient has undergone any facial, esophageal, gastric or sinus surgery within the
last 3 months.
7. The patient has idiopathic pulmonary fibrosis (IPF) as documented in their medical
history.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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