The Impact of Respiratory Training of DIBH Radiotherapy for Breast Cancer

June 27, 2024 updated by: Jianjun Lai

The Impact of Patients' Daily Independent Breathing Training on the Accuracy and Side Effects of Deep Inspiratory Breath-Hold Radiotherapy for Breast Cancer

Breast cancer DIBH (Deep Inspiration Breath Hold) radiotherapy represents a high-precision treatment approach that substantially minimizes radiation exposure to vital organs such as the heart, thus enhancing protection of the patient's heart, lungs, contralateral breast, and other normal tissues compared to conventional radiotherapy techniques. This method requires meticulous precision, necessitating that patients possess exceptional respiratory control, which is facilitated through specialized equipment. Without such control, patients may encounter issues like missed targets, significant setup errors, and extended treatment durations.

In this study, the research team employed portable devices to enable patients to independently perform daily respiratory training exercises. The control group received no such devices; instead, these patients were merely instructed verbally on the importance of improving their breath-holding capabilities. The effectiveness of this intervention was evaluated by comparing the daily setup errors between the two groups. Additionally, the intervention's influence on patient outcomes was assessed by monitoring the toxicity and side effects experienced by the patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Hospital
        • Contact:
          • Jianjun Lai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Breast Cancer Radiotherapy Patients
  • A single breath-hold can last for more than 10 seconds

Exclusion Criteria:

  • A single breath-hold can last for more than 10 seconds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Visualized Self-Training
Behavioral: Using a Portable Visualized Device for Self-Directed Breathing Training
Using a Portable Visualized Device for Self-Directed Breathing Training
No Intervention: No-Visualized Self-Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The daily measured setup error values of the image-guided radiotherapy device during the patient's treatment process.
Time Frame: 5 weeks
Statistical comparison and analysis of daily setup error values in patients are used to evaluate the effectiveness of the intervention measures.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jianjun Lai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDIBT001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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