Breast CancerNCT06488391
The Impact of Respiratory Training of DIBH Radiotherapy for Breast Cancer
A study testing Using a Portable Visualized Device for Self-Directed Breathing Training in people with Breast Cancer, run by Jianjun Lai at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Using a Portable Visualized Device for Self-Directed Breathing Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Breast Cancer Radiotherapy Patients
- A single breath-hold can last for more than 10 seconds
Who cannot join
- A single breath-hold can last for more than 10 seconds
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Hospital
Hangzhou, Zhejiang
Jianjun Lai
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Using a Portable Visualized Device for Self-Directed Breathing Training
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using a Portable Visualized Device for Self-Directed Breathing TrainingBehavioural
Using a Portable Visualized Device for Self-Directed Breathing Training
| Study group | Role | What they receive |
|---|---|---|
| Visualized Self-Training | Experimental | Not described Receives: Behavioral: Using a Portable Visualized Device for Self-Directed Breathing Training |
| No-Visualized Self-Training | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Jun 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianjun Lai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianjun Lai, Zhejiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488391
- Sponsor's protocol ID
- PDIBT001
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Patients' Daily Independent Breathing Training on the Accuracy and Side Effects of Deep Inspiratory Breath-Hold Radiotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT06488391
- Acronym / sponsor ID
- PDIBT001
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jianjun LaiUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visualized Self-Training | Experimental | Behavioral: Using a Portable Visualized Device for Self-Directed Breathing Training |
| No-Visualized Self-Training | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Breast Cancer Radiotherapy Patients
- A single breath-hold can last for more than 10 seconds
Key exclusion criteria (1 listed)
- A single breath-hold can last for more than 10 seconds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using a Portable Visualized Device for Self-Directed Breathing TrainingUsing a Portable Visualized Device for Self-Directed Breathing Training | Behavioural | Visualized Self-Training |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using a Portable Visualized Device for Self-Directed Breathing Training in people with Breast Cancer, run by Jianjun Lai at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianjun Lai (+8615924193343, 385806945@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The daily measured setup error values of the image-guided radiotherapy device during the patient's treatment process. (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.