Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04843306 |
| Other study ID # |
J20119 |
| Secondary ID |
IRB00265565 |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 3, 2021 |
| Est. completion date |
August 18, 2023 |
Study information
| Verified date |
June 2024 |
| Source |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Investigator proposes the development of an extended reality (xR) training platform for
patients undergoing radiation treatment for pancreatic cancer. The Investigator wants to
investigate the ability of this technology to provide biophysical feedback and coaching
during the planning and treatment sessions to help patients with the ABC technique to improve
motion management outcomes and reduce treatment related anxiety.
Description:
Pancreatic cancer (PCa) is a devastating diagnosis with one of the lowest 5-year overall
survival rates of all malignancies. It is estimated that at least 45,000 Americans will die
of this disease in 2019, making it the third most common cause of oncologic death. Of the
patients that present without evidence of distant spread at the time of diagnosis, only a
minority of patients are able to proceed directly to surgical resection which remains the
mainstay treatment modality. Historical outcomes show that 30-40% of patients present with
borderline resectable (BRPC) or locally advanced (LAPC) disease due to tumor involvement of
local vasculature which prevents the patients from proceeding directly to surgery. In this
context, neoadjuvant therapy with radiation is often administered in an attempt to downstage
tumors prior to surgery, reduce the risk of a margin positive failure, and reduce the risk of
local recurrence after surgery. For patients who are truly technically or medically
unresectable, radiation can be offered with the intent of providing durable local control.
Indeed, a recent autopsy study showed that 30 % of patients who expire from PCa do so due to
the locally destructive spread from this disease, highlighting the imperative need for an
optimal local control strategy.
Delivering radiation to the pancreas is technically challenging and must be carefully
delivered given the risk of injury to radiosensitive organs at risk (OAR) in close proximity
such as the bowel and stomach. Compounding this difficulty is the variation in positioning of
the tumor and OARs due to respiratory induced motion and variation in bowel gas patterns. To
achieve daily accuracy in tumor localization, the investigators employ a comprehensive
strategy including strict immobilization, endoscopically placed fiducials, and daily on-board
cone beam CT (CBCT). Moreover, the investigators utilize active breathing control (ABC),
which requires patients to reproducibly perform multiple deep-inspiratory breath holds during
treatment. Radiation to the pancreas is delivered only when the patient is holding patient's
breath. During ABC, patients breathe through a snorkel-like device that records the volume of
air inhaled during each breath. In this apparatus is a valve that will cut off the flow of
air once the inhalation volume passes a certain threshold to ensure the same amount of volume
is taken in each time a breath hold is performed. Patients are asked to press on a button to
start the recording aspect of the device and then to take a deep breath hold. Once patients
reach the desired threshold for the inhaled volume, the valve prevents any further air from
being inhaled in, and the patient is asked to hold patient's breath for a duration of 20 - 30
seconds. The treatment team is not present in the room with the patient because of radiation
exposure so it requires the patient to follow a series of with the treatment team over an
intercom system. Patients are asked to do this without any visual biophysical feedback of
patient's waveforms, and to do this repeatedly for multiple times per treatment session. The
series of instructions can be challenging for many patients, potentially leading to prolonged
treatment times and additional breath holds especially in the early fractions before patients
become more familiar with the system. Furthermore, with only one planning session to become
acquainted with the ABC device and treatment instructions, patients have limited practical
time to gain mastery before returning for patient's actual treatment sessions. This is of
concern since patients who struggle with the ABC technique may have less consistent
reproducibility of daily tumor positioning which may lead to poorer radiation treatment
outcomes.
The Investigator proposes the development of an extended reality (xR) training platform for
patients undergoing radiation treatment for pancreatic cancer. The Investigator wants to
investigate the ability of this technology to provide biophysical feedback and coaching
during the planning and treatment sessions to help patients with the ABC technique to improve
motion management outcomes and reduce treatment related anxiety.
