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RecruitingNCT06488391Updated Jul 5, 2024

The Impact of Respiratory Training of DIBH Radiotherapy for Breast Cancer

An interventional study of Using a Portable Visualized Device for Self-Directed Breathing Training in Breast Cancer, sponsored by Jianjun Lai. Recruiting at 1 site in China. Open to female participants. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by Jianjun Lai · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 80 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Jianjun Lai is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • A single breath-hold can last for more than 10 seconds
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Visualized Self-Training

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

  • No intervention
    No-Visualized Self-Training

Interventions

  • BehavioralUsing a Portable Visualized Device for Self-Directed Breathing Training

    Using a Portable Visualized Device for Self-Directed Breathing Training

06

What researchers measure

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.

    Time frame: 5 weeks

07

Study locations

1 of 1 sites recruiting
  • Zhejiang Hospital
    Hangzhou, Zhejiang, China
    • Jianjun Lai · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06488391
Lead sponsor
Jianjun Lai
Responsible party
Jianjun Lai (Advanced Medical Physicist, Zhejiang Hospital) — Sponsor-investigator
First posted
Jul 5, 2024
Start date
Jun 1, 2024
Primary completion
Jul 15, 2025 (estimated)
Completion
Jul 15, 2026 (estimated)
Last update
Jul 5, 2024

Study contacts

Jianjun Lai
Contact
385806945@qq.com
+8615924193343

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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