The Impact of Respiratory Training of DIBH Radiotherapy for Breast Cancer

NCT06488391 | Recruiting

• 1 other identifier: PDIBT001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The daily measured setup error values of the image-guided radiotherapy device during the patient's treatment process.

  Statistical comparison and analysis of daily setup error values in patients are used to evaluate the effectiveness of the intervention measures.

  5 weeks

Study Arms (2)

Visualized Self-Training

EXPERIMENTAL

Behavioral: Using a Portable Visualized Device for Self-Directed Breathing Training

No-Visualized Self-Training

NO INTERVENTION

Interventions

Using a Portable Visualized Device for Self-Directed Breathing Training BEHAVIORAL

Using a Portable Visualized Device for Self-Directed Breathing Training

Visualized Self-Training

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jianjun Lai: lead

Study Sites (1)

Zhejiang Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jianjun Lai

CONTACT

+8615924193343; 385806945@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Advanced Medical Physicist

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 5, 2024
• Study Start: June 1, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2026
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)