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 (Pa
Conditions
Interventions
None listed
Sponsors
Tosei General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligibility 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, followed by patient registration) Patients who meet all of the following criteria are eligible: 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 Additional Eligibility Criteria (These are additional eligibility criteria for this observational study and are evaluated at the end of A phase III study of High-Flow Nasal Cannula for relieving dyspnea in advanced cancer patients. Patients who met the initial eligibility criteria but do not meet the additional eligibility criteria at the time of evaluation can still be included in the observational study. If the additional eligibility criteria are not met, the six-day observation will not be conducted.) Patients who have completed the 24-hour evaluation in A phase III study of High-Flow Nasal Cannula for relieving dyspnea in advanced cancer patients. Patients who are scheduled to start or continue HFNC in routine clinical practice
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public Contactsatoshi hagimoto
Tosei General Hospital Department of Respiratory Medicine and Allergy
Outcome results
None listed