DyspneaPhase 2NCT06336642
Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology
A Phase 2 study testing SPOT-ON Early Start and SPOT-ON Delayed Start in people with Dyspnea, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn about the effect of Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON) treatment on the severity of shortness of breath in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- SPOT-ON Early Start and SPOT-ON Delayed Start
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2024to 31 Mar 2032
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cancer
- Age 18 or older.
- Admitted to a medical floor.
- Dyspnea intensity at rest of at least 4 on a 0-10-point NRS (where 0 = none, 10 = worst).
- Speak English or Spanish.
Who cannot join
- Hemodynamic instability requiring active Merit Team or ICU team involvement.
- Delirium as per clinical team's assessment in the Electronic Health Record (EHR).
- Severe hypoxemia (SpO2 < 90% despite supplemental oxygen of up to 6 L/min).
- Continuous positive airway pressure (CPAP) use for obstructive sleep apnea, actively using >10 hours a day.
- Respiratory failure necessitating mechanical ventilation (i.e., HFNC or NIV), and planned thoracentesis within 72 hours of enrollment.
- Patients with known pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
David Hui, MD, 713-792-6258, dhui@mdanderson.org
About this study
To learn about the effect of Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON) treatment on the severity of shortness of breath in patients with cancer.
Read the detailed description
Primary Objectives:
- To determine the effect of SPOT-ON and Enhanced Usual Care on the change in intensity of dyspnea (NRS) between baseline and 24 h in hypoxemic hospitalized patients with cancer.
- To determine the effect of SPOT-ON and Enhanced Usual Care on the change in intensity of dyspnea (NRS) between baseline and 24 h in non-hypoxemic hospitalized patients with cancer.
Secondary Objectives:
- To determine the effect of SPOT-ON and Enhanced Usual Care on patient outcomes over 72 h, including intensity of dyspnea (NRS), unpleasantness of dyspnea (NRS), dyspnea response, ital signs, symptom burden, health-related quality of life (EQ-5D-5L), adverse events, patterns of device use, and hospital outcomes.
- To identify factors associated with dyspnea response in the SPOT-ON intervention, including patient demographics, preferences, and level of usage of oxygen delivery modalities.
- To identify patient factors associated with their preferences (after Phase II and Phase III) for each of the oxygen delivery modalities in the SPOT-ON intervention, such as patient demographics and dyspnea characteristics.
- Conditions
- Dyspnea
- Being tested
- SPOT-ON Early Start, SPOT-ON Delayed Start
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPOT-ON Early StartBehavioural
Participants will start treatment within 3 days of enrollment, which may include: receiving information on breathing techniques, relaxation techniques, posture techniques, and distraction techniques, and/or trying different oxygen-based therapies, such as high-flow nasal cannula, low-flow supplemental oxygen, and non-invasive ventilation with a respiratory therapist.
SPOT-ON Delayed StartBehavioural
Participants will start treatment within 3 days of enrollment, which may include: receiving information on breathing techniques, relaxation techniques, posture techniques, and distraction techniques, and/or trying different oxygen-based therapies, such as high-flow nasal cannula, low-flow supplemental oxygen, and non-invasive ventilation with a respiratory therapist.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: SPOT-ON | Experimental | Participants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team. Receives: Behavioral: SPOT-ON Early Start; Behavioral: SPOT-ON Delayed Start |
| Group 2: SPOT-ON Waitlist | Experimental | Participants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team. Receives: Behavioral: SPOT-ON Early Start; Behavioral: SPOT-ON Delayed Start |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure: 1.Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Measured: [Time Frame: 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 posted29 Mar 2024
- Study start11 Jun 2024
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hui, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336642
- Sponsor's protocol ID
- 2023-0933
- Other IDs
- NCI-2024-02452
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hui D, Kim MJ, Thomas S, Sachdev G, Shete S, Rathi N, Hensch N, De La Cruz V, Ontai A, Mahler DA, Li J, Bruera E. Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON): A personalized randomized clinical trial protocol. PLoS One. 2025 Dec 2;20(12):e0336691. doi: 10.1371/journal.pone.0336691. eCollection 2025.
PubMed 41329762
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology
- ClinicalTrials.gov ID
- NCT06336642
- Acronym / sponsor ID
- 2023-0933
- Conditions
- Dyspnea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 29 Mar 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 about the effect of Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON) treatment on the severity of shortness of breath in patients with cancer.
Detailed description
Primary Objectives:
- To determine the effect of SPOT-ON and Enhanced Usual Care on the change in intensity of dyspnea (NRS) between baseline and 24 h in hypoxemic hospitalized patients with cancer.
- To determine the effect of SPOT-ON and Enhanced Usual Care on the change in intensity of dyspnea (NRS) between baseline and 24 h in non-hypoxemic hospitalized patients with cancer.
Secondary Objectives:
- To determine the effect of SPOT-ON and Enhanced Usual Care on patient outcomes over 72 h, including intensity of dyspnea (NRS), unpleasantness of dyspnea (NRS), dyspnea response, ital signs, symptom burden, health-related quality of life (EQ-5D-5L), adverse events, patterns of device use, and hospital outcomes.
- To identify factors associated with dyspnea response in the SPOT-ON intervention, including patient demographics, preferences, and level of usage of oxygen delivery modalities.
- To identify patient factors associated with their preferences (after Phase II and Phase III) for each of the oxygen delivery modalities in the SPOT-ON intervention, such as patient demographics and dyspnea characteristics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: SPOT-ON | Experimental | Behavioral: SPOT-ON Early Start, Behavioral: SPOT-ON Delayed StartParticipants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team. |
| Group 2: SPOT-ON Waitlist | Experimental | Behavioral: SPOT-ON Early Start, Behavioral: SPOT-ON Delayed StartParticipants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of cancer
- Age 18 or older.
- Admitted to a medical floor.
- Dyspnea intensity at rest of at least 4 on a 0-10-point NRS (where 0 = none, 10 = worst).
- Speak English or Spanish.
Key exclusion criteria (6 listed)
- Hemodynamic instability requiring active Merit Team or ICU team involvement.
- Delirium as per clinical team's assessment in the Electronic Health Record (EHR).
- Severe hypoxemia (SpO2 < 90% despite supplemental oxygen of up to 6 L/min).
- Continuous positive airway pressure (CPAP) use for obstructive sleep apnea, actively using >10 hours a day.
- Respiratory failure necessitating mechanical ventilation (i.e., HFNC or NIV), and planned thoracentesis within 72 hours of enrollment.
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 |
|---|---|---|
| SPOT-ON Early StartParticipants will start treatment within 3 days of enrollment, which may include: receiving information on breathing techniques, relaxation techniques, posture techniques, and distraction techniques, and/or trying different oxygen-based therapies, such as high-flow nasal cannula, low-flow supplemental oxygen, and non-invasive ventilation with a respiratory therapist. | Behavioural | Group 1: SPOT-ON, Group 2: SPOT-ON Waitlist |
| SPOT-ON Delayed StartParticipants will start treatment within 3 days of enrollment, which may include: receiving information on breathing techniques, relaxation techniques, posture techniques, and distraction techniques, and/or trying different oxygen-based therapies, such as high-flow nasal cannula, low-flow supplemental oxygen, and non-invasive ventilation with a respiratory therapist. | Behavioural | Group 1: SPOT-ON, Group 2: SPOT-ON Waitlist |
Primary outcome
Primary Outcome Measure: 1.Safety and adverse events (AEs)
Time frame: [Time Frame: Through study completion; an average of 1 year.]
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
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 24 Sep 2026.
- Derived from this study: PubMed 41329762Hui D, Kim MJ, Thomas S, Sachdev G, Shete S, Rathi N, Hensch N, De La Cruz V, Ontai A, Mahler DA, Li J, Bruera E. Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON): A personalized randomized clinical trial protocol. PLoS One. 2025 Dec 2;20(12):e0336691. doi: 10.1371/journal.pone.0336691. eCollection 2025.
- MD Anderson Cancer Center WebsiteLink 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.
David Hui, MD 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 Phase 2 study testing SPOT-ON Early Start and SPOT-ON Delayed Start in people with Dyspnea, 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact David Hui, MD ((713) 792-6258, dhui@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure: 1.Safety and adverse events (AEs) (time frame: [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?
On the ClinicalTrials.gov record for NCT06336642, which also lists 1 linked publication.
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 24 Sep 2026.