Management of Breathlessness with High-flow Nasal Therapy or a Fan

NCT05257850 | Completed

• 1 other identifier: R20049
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Airflow directed to the face by a fan is shown to relief breathlessness in palliative care and some studies have suggested High-Flow nasal airflow therapy beneficial as well. However, these two treatments have not been compared. 40 patients with advanced cancer and breathlessness are recruited from Tampere University Hospital or Pirkanmaa Hospice. All patients are treated with two therapies: 1. High-Flow nasal airflow therapy with a nasal cannula and 2. airflow directed to the face by a fan. Both treatment periods last 30 minutes or as long as the patient wish to use the therapy. The effects of the therapies on breathlessness are compared by asking the subjective relief of breathlessness after each therapies. The study do not limit any other therapies used in the normal clinical care for the patients. Thus, all the other therapies the physicians taking care of the patient orders are permitted. Hopefully, the patients achieve relief for their breathlessness through the study treatments given in addition to their normal treatment. There are no significant risks related to the therapies, but they may cause some inconveniences such as mouth dryness. These possible side-effects of the therapies are asked as well.

Conditions

Breathlessness; Cancer

Outcome Measures

Primary Outcomes (1)

• Breathlessness after the study treatments (difference between the High-Flow Nasal Therapy and a fan)

  The breathlessness after the study treatments measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness).

  Measurements are made immediately before and immediately after the treatment period.

Secondary Outcomes (9)

• Change in breathlessness before and after the treatments

  Measurements are made immediately before and immediately after the treatment period.

• Change in mouth dryness before and after the treatments

  Measurements are made immediately before and immediately after the treatment period.

• Change in anxiety before and after the treatments

  Measurements are made immediately before and immediately after the treatment period.

• Change in pain before and after the treatments

  Measurements are made immediately before and immediately after the treatment period.

• Change in respiratory frequency with the treatments

  Measurements are made immediately before and immediately after the treatment period.

Study Arms (2)

Fan first

ACTIVE COMPARATOR

Patients use the fan first and high-flow nasal therapy thereafter

Device: High-flow nasal therapy; Device: Airflow directed to face by a fan

High-flow nasal therapy first

ACTIVE COMPARATOR

Patients use high-flow nasal therapy first and the fan thereafter

Device: High-flow nasal therapy; Device: Airflow directed to face by a fan

Interventions

High-flow nasal therapy DEVICE

A high-flow nasal therapy for 30 minutes.

Fan first; High-flow nasal therapy first

Airflow directed to face by a fan DEVICE

A fan directed to the face for 30 minutes

Fan first; High-flow nasal therapy first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced cancer
• At least 18 years of age
• Breathlessness (At least 3 on a NRS-scale from 0 to 10)
• Capable to understand the study and to give informed consent
• Do not benefit from ICU treatment or resuscitation defined by the physician taking care of the patient

You may not qualify if:

• Insufficient co-operation for the study treatment or to give informed consent
• Oxygen saturation under 88 % on room air
• Need for other device to treat the breathlessness
• The reason of breathlessness can be immediately treated

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (2)

Pirkanmaa Hospice

Tampere, 33520, Finland

Location

Tampere University Hospital

Tampere, 33520, Finland

Location

Related Publications (1)

• Leivo-Korpela S, Rantala HA, Lehtimaki L, Piili RP, Hasala H, Korhonen T, Lehto JT. Management of Dyspnea With High-Flow Nasal Air or Fan-A Randomized Controlled Crossover Trial. J Pain Symptom Manage. 2026 Jan;71(1):8-15. doi: 10.1016/j.jpainsymman.2025.08.033. Epub 2025 Sep 4.

  PMID: 40914402 DERIVED

MeSH Terms

Conditions

Dyspnea; Neoplasms

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juho Lehto, Professor

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD,Professor

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: February 25, 2022
• Study Start: April 26, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)