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Breath-Hold Technique with Biofeedback for Pancreatic Cancer

N/A
Recruiting
Led By Amol Narang
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women over 18 years of age
Receiving stereotactic body radiation therapy for pancreatic cancer with active breathing control (ABC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months from final sbrt session
Awards & highlights

Study Summary

This trial will test a new extended reality (xR) training platform for patients undergoing radiation treatment for pancreatic cancer. The platform will 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.

Who is the study for?
This trial is for adults over 18 with a confirmed diagnosis of pancreatic cancer that's borderline resectable or locally advanced. Participants must be undergoing SBRT for pancreatic cancer and able to understand English, with or without an interpreter. Those who can't consent, have seizure history, refuse to answer study questions or use the xR device are excluded.Check my eligibility
What is being tested?
The trial is testing an extended reality (xR) training platform designed to assist patients in using the Active Breathing Control (ABC) technique during radiation therapy. The goal is to see if this tech improves motion management and reduces anxiety during treatment.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from using biofeedback devices and stress related to learning new technology under health-related duress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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I am undergoing targeted radiation for pancreatic cancer with a technique to control my breathing.
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My pancreatic cancer is at a stage where surgery might be possible or it has spread locally.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months from final sbrt session
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months from final sbrt session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness of motion management for SBRT for pancreatic cancer with real-time coaching for the ABC procedure using an augmented reality platform
Secondary outcome measures
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)
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)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ABC technique plus biofeedbackExperimental Treatment2 Interventions
Patients will utilize biophysical feedback and coaching during the planning and treatment sessions for radiotherapy to help patients with the ABC technique.
Group II: Standard of care ABC technique.Active Control1 Intervention
Patients will standard of care instructions for using the ABC technique during the planning and treatment sessions for radiotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biofeedback
2016
Completed Phase 4
~1280

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,860 Total Patients Enrolled
Amol NarangPrincipal InvestigatorJohns Hopkins University

Media Library

Active Breathing Control Technique Clinical Trial Eligibility Overview. Trial Name: NCT04843306 — N/A
Pancreatic Cancer Research Study Groups: ABC technique plus biofeedback, Standard of care ABC technique.
Pancreatic Cancer Clinical Trial 2023: Active Breathing Control Technique Highlights & Side Effects. Trial Name: NCT04843306 — N/A
Active Breathing Control Technique 2023 Treatment Timeline for Medical Study. Trial Name: NCT04843306 — N/A

Frequently Asked Questions

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

What is the overall participation of this research study?

"Affirmative. The information uploaded on clinicaltrials.gov affirms that this medical study, originally posted on June 24th 2021, is presently in search of participants. 20 individuals must be recruited from a single research site."

Answered by AI

Are there any openings for participants in this research endeavor?

"Affirmative. Clinicaltrials.gov attests to this study's recruitment efforts, which started on June 24th 2021 and were last updated September 1st 2022, with a need for 20 participants at one medical centre."

Answered by AI
~8 spots leftby Dec 2025