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Pancreas CancerNCT04843306

Breath-Hold Technique for Pancreatic Stereotactic Body Radiation Therapy (SBRT) Patients

A study testing Biofeedback in people with Pancreas Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreas Cancer
What is being tested?
Biofeedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
3 Jun 2021to 18 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women over 18 years of age
  • Patients with a histologically confirmed diagnosis of pancreatic cancer with borderline resectable or locally advanced disease
  • Receiving stereotactic body radiation therapy for pancreatic cancer with active breathing control (ABC)
  • Able to read and write in English or able to understand/answer study questions and instructions with the aid of an interpreter

Who cannot join

  • Patients who do not provide informed consent
  • Patients who chose not to answer the study questions
  • Patients who chose not to use the xR device and platform
  • Patients with a seizure history

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

Other trials in United States

About this study

Official title: "Real-time Augmented Reality Coaching for the Breath-Hold Technique for Pancreatic SBRT Patients"

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.

Read the detailed 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.

Conditions
Pancreas Cancer
Being tested
Biofeedback, Active Breathing Control Technique
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiofeedbackBehavioural

    Relaxation coaching will be used in this study.

  • Active Breathing Control TechniqueBehavioural

    Active breathing control (ABC) requires patients to reproducibly perform multiple deep-inspiratory breath holds during treatment.

Study groups in NCT04843306
Study groupRoleWhat they receive
ABC technique plus biofeedbackExperimentalPatients will utilize biophysical feedback and coaching during the planning and treatment sessions for radiotherapy to help patients with the ABC technique.
Receives: Behavioral: Biofeedback; Behavioral: Active Breathing Control Technique
Standard of care ABC technique.Active comparatorPatients will standard of care instructions for using the ABC technique during the planning and treatment sessions for radiotherapy.
Receives: Behavioral: Active Breathing Control Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness of motion management for SBRT for pancreatic cancer with real-time coaching for the ABC procedure using an augmented reality platform

    The mean range of intra-fraction variation (in millimeters) will be used in assessing the effectiveness of motion management. The result will be compared to historical controls in a "pick the winner" design.

    Measured: Up to 3 months from final SBRT session

Secondary outcomes (2)
  1. Quality of patient confidence with the ABC procedure with real-time coaching using an augmented reality platform during SBRT for pancreatic cancer as assessed by patient reported outcome measures (PROMs)

    Patient confidence will be assessed with PROMs and the mean score for all patients treated in AR mode 1 will be compared to the mean score for all patients treated in AR mode 2. This PROM consists of 8 questions on a 5-point Likert scale to assess the patient's confidence in performing the ABC procedure with AR mode 1 or 2, and total score ranges from 0 to 32 with higher score signifying greater confidence.

    Measured: Up to 3 months from final SBRT session

  2. Anxiety of patient with the ABC procedure with real-time coaching using an augmented reality platform during SBRT for pancreatic cancer as assessed by patient reported outcome measures (PROMs)

    Patient anxiety will be assessed with PROMs and the mean score for all patients treated in AR mode 1 will be compared to the mean score for all patients treated in AR mode 2. This PROM consists of 20 questions on a 4-point Likert scale to assess patient anxiety with the ABC procedure and total score ranges from 20 to 80 with higher scores signifying greater anxiety with the procedure.

    Measured: Up to 3 months from final SBRT session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2021
  2. Study start3 Jun 2021
  3. Primary completion18 Aug 2023
  4. Study completion18 Aug 2023

Why it stopped: Technical difficulties that were not able to be resolved.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
This will be a prospective, randomized, and non-blinded trial to assess the benefit of xR technology for patient education, coaching, and comfort during radiation treatment of pancreatic cancer. Prior to any use of the xR platform for patients, the investigators will perform several dry runs with the Radiation Oncology Physics department to confirm the device and platform can be used safely.
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04843306
Sponsor's protocol ID
J20119
Other IDs
IRB00265565
Status last verified
Jun 2024
First submitted
8 Apr 2021
Last updated
7 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Biofeedback in people with Pancreas Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Technical difficulties that were not able to be resolved.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of motion management for SBRT for pancreatic cancer with real-time coaching for the ABC procedure using an augmented reality platform (time frame: Up to 3 months from final SBRT session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.

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