Multicenter Prospective Observational Study to Investigate the Tolerability of Long-Term HFNC in Patients with Advanced Cancer and Poor Performance Status Experiencing Dyspnea at Rest

UMIN ID: UMIN000056675

Registered date:09/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients who have received a pathological or clinical diagnosis of advanced cancer before registration Patients with an ECOG PS of 3 or 4 (as determined by at least two physicians) Patients with subjective symptoms of dyspnea that have worsened over the two weeks prior to registration Patients who experience dyspnea at rest with an mBorg scale score of 3 or higher at the time of registration (initial eligibility assessment) Patients who cannot maintain an arterial oxygen partial pressure (PaO2) of 60 Torr or more or an SpO2 of 90% or more on room air at rest Patients who are 18 years of age or older at the time of consent acquisition
• Date of first enrollment: 2024/07/26
• Target sample size: 54
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Total duration of HFNC use over six days from the end of a phase III study of High-Flow Nasal Cannula for relieving dyspnea in advanced cancer patients. The duration of HFNC use is defined as the period from the start of observation until the criteria for discontinuing HFNC are met. The discontinuation of HFNC in this study is defined as not using HFNC continuously for more than 12 hours.
• Secondary Outcome: Evaluate the changes in the mBorg Scale for dyspnea at rest over six days. Assess the response rate. Evaluate the desire to continue HFNC therapy.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Exclusion Criteria (The same as those of A phase III study of High-Flow Nasal Cannula for relieving dyspnea in advanced cancer patients, and evaluated simultaneously with the eligibility criteria for that trial) 1.Patients currently receiving mechanical ventilation, including NPPV, where the continuation of mechanical ventilation is deemed medically appropriate 2.Patients scheduled to receive mechanical ventilation, including NPPV 3.Patients using HFNC at the time of registration 4.Patients with impaired consciousness, cognitive dysfunction, or mental illness that prevents appropriate communication 5.Patients receiving continuous sedation 6.Patients using opioid rescue medication more than eight times a day 7.Patients participating in other clinical trials that could affect the evaluation and results of this study 8.Patients who started the following treatments within 28 days before registration or are scheduled to start these treatments during the trial period: Surgical treatments, anticancer therapies, or chest radiotherapy for the primary disease that could improve dyspnea 9.Patients who started the following treatments within seven days before registration or are scheduled to start these treatments during the trial period: Intravenous antibiotics for bacteremia or pneumonia that could improve dyspnea 10.Patients who started the following treatments within 24 hours before registration or are scheduled to start these treatments during the trial period: Thoracentesis, drainage of the pleural cavity, or pericardiocentesis 11.Other cases deemed inappropriate for participation in this clinical study by the principal investigator or sub-investigator Additional Exclusion Criteria Patients with impaired consciousness, cognitive dysfunction, or mental illness at the start of the observational study that prevents appropriate communication for clinical study evaluation

Related Information

• Primary Sponsor: Tosei General Hospital
• Source(s) of Monetary Support: none