Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-01-01 @ 6:03 PM
Study NCT ID:
NCT05257850
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2022-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Breathlessness with High-flow Nasal Therapy or a Fan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2022-01-16', 'studyFirstSubmitQcDate': '2022-02-23', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breathlessness after the study treatments (difference between the High-Flow Nasal Therapy and a fan)', 'timeFrame': 'Measurements are made immediately before and immediately after the treatment period.', 'description': 'The breathlessness after the study treatments measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness).'}], 'secondaryOutcomes': [{'measure': 'Change in breathlessness before and after the treatments', 'timeFrame': 'Measurements are made immediately before and immediately after the treatment period.', 'description': 'Change in breathlessness before and after the treatments measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness).'}, {'measure': 'Change in mouth dryness before and after the treatments', 'timeFrame': 'Measurements are made immediately before and immediately after the treatment period.', 'description': '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).'}, {'measure': 'Change in anxiety before and after the treatments', 'timeFrame': 'Measurements are made immediately before and immediately after the treatment period.', 'description': 'Change in anxiety before and after the treatments measured by numeric rating scale (NRS) from 0 (no anxiety) to 10 (the worst possible anxiety).'}, {'measure': 'Change in pain before and after the treatments', 'timeFrame': 'Measurements are made immediately before and immediately after the treatment period.', 'description': 'Change in pain before and after the treatments measured by numeric rating scale (NRS) from 0 (no pain) to 10 (the worst possible pain).'}, {'measure': 'Change in respiratory frequency with the treatments', 'timeFrame': 'Measurements are made immediately before and immediately after the treatment period.', 'description': 'Change in respiratory frequency measured by calculating breaths per minute.'}, {'measure': 'Change in heart rate with the treatments', 'timeFrame': 'Measurements are made immediately before and immediately after the treatment period.', 'description': 'Change in heart rate measured by calculating heart beats per minute.'}, {'measure': 'Change in oxygen saturation with the treatments', 'timeFrame': 'Measurements are made immediately before and immediately after the treatment period.', 'description': 'Change in peripheral oxygen saturation (%) measured with pulse oximeter.'}, {'measure': 'Proportion of patients reporting to have overall benefit of the treatments', 'timeFrame': 'Opinion is asked immediately after the treatment', 'description': 'Proportion of patients reporting to have overall benefit of the treatments'}, {'measure': 'Proportion of patients who report side-effects of the treatments', 'timeFrame': 'Experienced side-effects are asked immediately after the treatment', 'description': 'Proportion of patients who report side-effects of the treatments'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breathlessness', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '40914402', 'type': 'DERIVED', 'citation': '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. 2025 Sep 4:S0885-3924(25)00813-9. doi: 10.1016/j.jpainsymman.2025.08.033. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': '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.\n\n40 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.', 'detailedDescription': '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 and High-Flow nasal airflow therapy has not been tested in the context of hospice.\n\n40 patients over 18 years 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 (crossover trial). 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 with numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness). Influence of the treatments on anxiety, pain and mouth dryness are measured as well with numeric rating scale (NRS) from 0 to 10. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced cancer\n* At least 18 years of age\n* Breathlessness (At least 3 on a NRS-scale from 0 to 10)\n* Capable to understand the study and to give informed consent\n* Do not benefit from ICU treatment or resuscitation defined by the physician taking care of the patient\n\nExclusion Criteria:\n\n* Insufficient co-operation for the study treatment or to give informed consent\n* Oxygen saturation under 88 % on room air\n* Need for other device to treat the breathlessness\n* The reason of breathlessness can be immediately treated'}, 'identificationModule': {'nctId': 'NCT05257850', 'briefTitle': 'Management of Breathlessness with High-flow Nasal Therapy or a Fan', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Management of Breathlessness with High-flow Nasal Therapy or a Fan', 'orgStudyIdInfo': {'id': 'R20049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fan first', 'description': 'Patients use the fan first and high-flow nasal therapy thereafter', 'interventionNames': ['Device: High-flow nasal therapy', 'Device: Airflow directed to face by a fan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-flow nasal therapy first', 'description': 'Patients use high-flow nasal therapy first and the fan thereafter', 'interventionNames': ['Device: High-flow nasal therapy', 'Device: Airflow directed to face by a fan']}], 'interventions': [{'name': 'High-flow nasal therapy', 'type': 'DEVICE', 'description': 'A high-flow nasal therapy for 30 minutes.', 'armGroupLabels': ['Fan first', 'High-flow nasal therapy first']}, {'name': 'Airflow directed to face by a fan', 'type': 'DEVICE', 'description': 'A fan directed to the face for 30 minutes', 'armGroupLabels': ['Fan first', 'High-flow nasal therapy first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33520', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Pirkanmaa Hospice', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '33520', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Juho Lehto, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,PhD,Professor', 'investigatorFullName': 'Juho Lehto', 'investigatorAffiliation': 'Tampere University Hospital'}}}}