ClinicalTrials.gg
Sign In
RecruitingNCT06336642Updated Sep 24, 2026

Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology

A Phase 2 interventional study of SPOT-ON Early Start and SPOT-ON Delayed Start in Dyspnea, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Supportive care

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 the detailed description

Primary Objectives:

  1. 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.
  2. 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:

  1. 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.
  2. To identify factors associated with dyspnea response in the SPOT-ON intervention, including patient demographics, preferences, and level of usage of oxygen delivery modalities.
  3. 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.
02

Conditions studied

  • Dyspnea

Browse trials for

03

In context

Dyspnea

894 studies on the registry are indexed under Dyspnea; 189 are open to participants now.

This study's planned enrollment of 150 is above the median of 50 across 587 interventional studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Browse M.D. Anderson Cancer Center studies →

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Group 1: SPOT-ON

    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.

    Behavioral: SPOT-ON Early Start · Behavioral: SPOT-ON Delayed Start

  • Experimental
    Group 2: SPOT-ON Waitlist

    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.

    Behavioral: SPOT-ON Early Start · Behavioral: SPOT-ON Delayed Start

Interventions

  • BehavioralSPOT-ON Early Start

    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.

  • BehavioralSPOT-ON Delayed Start

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: [Time Frame: Through study completion; an average of 1 year.]

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Mar 2030, 69 months after the start.

Of 23 phase 2 interventional studies under Dyspnea, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 77. This study's planned 69 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2024
First posted
Mar 29, 2024
StartActual
Jun 11, 2024
Primary completionEst.
Mar 31, 2030
CompletionEst.
Mar 31, 2032
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06336642
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Mar 29, 2024
Start date
Jun 11, 2024
Primary completion
Mar 31, 2030 (estimated)
Completion
Mar 31, 2032 (estimated)
Last update
Sep 24, 2026

Study contacts

David Hui, MD
Contact
dhui@mdanderson.org
(713) 792-6258
David Hui, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dyspnea →

Other studies from this sponsor

M.D. Anderson Cancer Center →

Start the discussion