- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06488391
The Impact of Respiratory Training of DIBH Radiotherapy for Breast Cancer
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jianjun Lai
- Phone Number: +8615924193343
- Email: 385806945@qq.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Recruiting
- Zhejiang Hospital
-
Contact:
- Jianjun Lai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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