A study comparing High-Flow Nasal Cannula with conventional oxygen therapy for relieving dyspnea in advanced cancer patients

JRCT ID: jRCT1052240029

Registered date:10/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced cancer
• Date of first enrollment: 06/06/2024
• Target sample size: 72
• Study type: Interventional
• Intervention(s): COT in the standard treatment group and HFNC in the study treatment group for 24 hours .

Outcome(s)

• Primary Outcome: Change of mean mBorg scale at 24 hours

Secondary Outcome

1.Response rate.
2.Retention rate of protocol treatment.
3.Changes of mBorg scale at the each time point.
4.Respiratory rate at the each time point.
5.Pulse rate at the each time point.
6.SpO2 at the each time point.
7.Japan Coma Scale at the each time point.
8.Numerical Rating Scale of comfort level at the each time point.
9.Opioid use at the each time point.
10.Sedative medication use at the each time point.
11.Percentage of patients wishing to continue with HFNC after 24 hours.
12.HFNC setting.
13.Overall survival.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Have a pathological or clinical diagnosis of advanced cancer at the time of registration.
(2) Performance score of 3 or 4 (determined by at least two physicians).
(3) Symptoms of dyspnea had a tendency to worsen in the two weeks before registration.
(4) Dyspnea at rest with mBorg scale 3 or higher at the time of registration.
(5) Inability to maintain arterial partial pressure of oxygen: >=60 Torr or SpO2: >=90% with room air at rest.
(6) Age of 18 years or older at the time of giving consent.
(7) Understanding of the study procedures and written consent to participate in it.

Exclude criteria

(1) Patient is on invasive mechanical ventilation (IMV) or non-invasive positive pressure ventilation (NPPV) and continuation of IMV or NPPV is medically justified.
(2) Ventilatory management including NPPV is planned.
(3) HFNC is being used at the time of consent.
(4) Inability to communicate adequately due to impaired consciousness, cognitive impairment, or psychiatric disease.
(5) Receiving continuous sedation.
(6) Takes additional opioid as needed more than 8 times a day.
(7) Participating in another clinical trial that may affect the evaluation or results of this study.
(8) Have initiated or will initiate the following treatment within 28 days prior to enrollment:
Surgical treatment, anticancer drug treatment, or thoracic radiotherapy for cancer that may improve dyspnea.
(9) Have started or are scheduled to start within 7 days prior to enrollment:
Therapeutic intravenous antibacterial agents for bacteremia or pneumonia that may improve dyspnea.
(10) Have started the following treatment within 24 hours prior to enrollment or are scheduled to start within the study period:
Thoracentesis/drainage, pericardiocentesis/drainage.
(11) Participation in this clinical research deemed inappropriate by doctors.

Related Information

• Primary Sponsor: Akamatsu Hiroaki