Cancer Clinical Trial
Official title:
Management of Breathlessness With High-flow Nasal Therapy or a Fan
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Finland | Pirkanmaa Hospice | Tampere | |
Finland | Tampere University Hospital | Tampere |
Lead Sponsor | Collaborator |
---|---|
Tampere University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in breathlessness before and after the treatments | Change in breathlessness before and after the 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 | Change in mouth dryness before and after the treatments | Change in mouth dryness before and after the treatments measured by numeric rating scale (NRS) from 0 (no mouth dryness) to 10 (the worst possible mouth dryness). | Measurements are made immediately before and immediately after the treatment period. | |
Secondary | Change in anxiety before and after the treatments | Change in anxiety before and after the treatments measured by numeric rating scale (NRS) from 0 (no anxiety) to 10 (the worst possible anxiety). | Measurements are made immediately before and immediately after the treatment period. | |
Secondary | Change in pain before and after the treatments | Change in pain before and after the treatments measured by numeric rating scale (NRS) from 0 (no pain) to 10 (the worst possible pain). | Measurements are made immediately before and immediately after the treatment period. | |
Secondary | Change in respiratory frequency with the treatments | Change in respiratory frequency measured by calculating breaths per minute. | Measurements are made immediately before and immediately after the treatment period. | |
Secondary | Change in heart rate with the treatments | Change in heart rate measured by calculating heart beats per minute. | Measurements are made immediately before and immediately after the treatment period. | |
Secondary | Change in oxygen saturation with the treatments | Change in peripheral oxygen saturation (%) measured with pulse oximeter. | Measurements are made immediately before and immediately after the treatment period. | |
Secondary | Proportion of patients reporting to have overall benefit of the treatments | Proportion of patients reporting to have overall benefit of the treatments | Opinion is asked immediately after the treatment | |
Secondary | Proportion of patients who report side-effects of the treatments | Proportion of patients who report side-effects of the treatments | Experienced side-effects are asked immediately after the treatment |
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