Personalized oxygen therapy for cancer patients with shortness of breath
Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology
PHASE2; PHASE3 · M.D. Anderson Cancer Center · NCT06336642
This study is testing a new personalized oxygen therapy to see if it helps hospitalized cancer patients with shortness of breath feel better compared to standard care.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06336642 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON) on alleviating shortness of breath in hospitalized cancer patients. It aims to compare the effectiveness of SPOT-ON against Enhanced Usual Care in both hypoxemic and non-hypoxemic patients. The study will assess changes in dyspnea intensity and other patient outcomes over a 72-hour period, while also exploring factors influencing patient responses to the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with advanced cancer experiencing moderate to severe dyspnea.
Not a fit: Patients with severe hypoxemia, respiratory failure, or those requiring intensive care are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of dyspnea in cancer patients, enhancing their quality of life.
How similar studies have performed: Previous studies have shown promise in using personalized oxygen therapies for dyspnea management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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.
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: David Hui, MD — M.D. Anderson Cancer Center
- Study coordinator: David Hui, MD
- Email: dhui@mdanderson.org
- Phone: (713) 792-6258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dyspnea