Breathing, MouthNCT06747533
Impact of Diaphragmatic Breathing Coaching on Deep Inspiration Breath Hold Reproducibility and Organ Protection
A study testing CT simulation in people with Breathing, Mouth, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if coaching participants on diaphragmatic breathing will help participants to take larger, more reproducible breaths and feel less anxiety about their treatments. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breathing, Mouth
- What is being tested?
- CT simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Left sided breast cancer planned for whole breast radiation or any breast cancer requiring treatment of the regional nodes
- Treatment planned at the MDACC Mays Breast Radiation Oncology clinic
Who cannot join
- Underlying lung issues that may limit ability to achieve ideal breath hold (COPD on oxygen, etc)
- Active pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
To learn if coaching participants on diaphragmatic breathing will help participants to take larger, more reproducible breaths and feel less anxiety about their treatments.
Read the detailed description
Primary Objectives The primary objective is to compare the average daily shift for participant treatment for participant who have had coaching with https://www.thebreathingclass.com/cancer-center/participant versus participant who had standard clinic teaching.
- Conditions
- Breathing, Mouth
- Being tested
- CT simulation
- Medical subject headings
- Mouth Breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT simulationOther
Given by lung function test (spirometry) and questionnaire about treatment anxiety and satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| Standard Patient Education | Experimental | If participants are in the Standard Participants Education group, participants will receive standard of care participants education. Receives: Other: CT simulation |
| Breathe Radiation Protocol Coaching group | Experimental | If participants are in the Breathe Radiation Protocol Coaching group, you will have access to a video that helps guide you through a relaxed breath hold for the radiation treatment and also access to a coach for questions about the breathing process during radiation. This coaching will take place in the week before you undergo radiation planning. Receives: Other: CT simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start8 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing, MouthStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Mitchell, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747533
- Sponsor's protocol ID
- 2024-1120
- Other IDs
- NCI-2024-10404
- Status last verified
- May 2026
- First submitted
- 16 Dec 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Diaphragmatic Breathing Coaching on Deep Inspiration Breath Hold Reproducibility and Organ Protection
- ClinicalTrials.gov ID
- NCT06747533
- Acronym / sponsor ID
- 2024-1120
- Conditions
- Breathing, Mouth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Dec 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.
To learn if coaching participants on diaphragmatic breathing will help participants to take larger, more reproducible breaths and feel less anxiety about their treatments.
Detailed description
Primary Objectives The primary objective is to compare the average daily shift for participant treatment for participant who have had coaching with https://www.thebreathingclass.com/cancer-center/participant versus participant who had standard clinic teaching.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Patient Education | Experimental | Other: CT simulationIf participants are in the Standard Participants Education group, participants will receive standard of care participants education. |
| Breathe Radiation Protocol Coaching group | Experimental | Other: CT simulationIf participants are in the Breathe Radiation Protocol Coaching group, you will have access to a video that helps guide you through a relaxed breath hold for the radiation treatment and also access to a coach for questions about the breathing process during radiation. This coaching will take place in the week before you undergo radiation planning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- Left sided breast cancer planned for whole breast radiation or any breast cancer requiring treatment of the regional nodes
- Treatment planned at the MDACC Mays Breast Radiation Oncology clinic
Key exclusion criteria (2 listed)
- Underlying lung issues that may limit ability to achieve ideal breath hold (COPD on oxygen, etc)
- Active pregnancy
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 |
|---|---|---|
| CT simulationGiven by lung function test (spirometry) and questionnaire about treatment anxiety and satisfaction. | Other | Breathe Radiation Protocol Coaching group, Standard Patient Education |
Primary outcome
Safety and Adverse Events
Time frame: Through study completion; an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Melissa Mitchell principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT simulation in people with Breathing, Mouth, run by M.D. Anderson Cancer Center at 1 site in United States.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (time frame: Through study completion; an average of 1 year). 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 22 May 2026.