The Impact of Respiratory Training of DIBH Radiotherapy for Breast Cancer

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Behavioral: Using a Portable Visualized Device for Self-Directed Breathing Training

• Registration Number: NCT06488391
• Lead Sponsor: Jianjun Lai

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-01
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-07-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Visualized Self-Training	Using a Portable Visualized Device for Self-Directed Breathing Training	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Zhejiang Hospital; 🇨🇳 Hangzhou, Zhejiang, China