Clinical trial · Interventional
Non-invasive Ventilation in Terminally Ill Cancer Patients
Multicenter, Randomised Study of the Use of Non-Invasive Ventilation (NIV) Versus Oxygen Therapy (O2) in Reducing Dyspnea in End-stage Solid Cancer Patients With Respiratory Failure and Distress
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The occurrence of acute respiratory failure (ARF) is often seen by oncologists as a terminal phase of the disease, this view being based on studies reporting limited survival at considerable costs in such patients. A large proportion of cancer patients with severe respiratory failure are denied admission to an ICU because intensive care specialists are aware that intubation and mechanical ventilation are both strong predictors of mortality in critically ill cancer patients. This holds particularly true in the subset of patients who are not receiving chemotherapy or radiotherapy because of the advanced stage of their disease, and who are also not affected by an episode of ARF, related to a reversible cause. These patients often receive oxygen therapy and morphine in an attempt to improve oxygenation and/or relieve the ensuing dyspnea. Non-invasive mechanical ventilation (NIV) is now the first line treatment of ARF in selected populations (e.g., those with COPD) and has been used sporadically as a potential treatment of acute respiratory failure in patients with a "do-not-intubate" order. The International Consensus Conference on Intensive Care Medicine stated that "the use of NIV may be justified in selected patients who are "not to be intubated" and may provide patient comfort and facilitate physician-patient interaction." "Early" NIV has been successfully used so far in cancer patients only to prevent intubation among those with hematologic malignancies, while a pilot study has assessed the feasibility of NIV also as a "palliative" treatment of end-stage solid cancer patients. So far we are lacking data about the "pure palliative" effects of NIV,in patients with end-stage solid cancer. The aim of this multicenter randomised study will be to evaluate on a large scale the feasibility, clinical efficacy and impact on quality of life and dyspnea of NIV versus standard medical in patients with respiratory failure, not related to a reversible cause, and solid cancer needing palliative care treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| non invasive ventilation (NIV) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 2
- description
- Non-invasive ventilation
- interventionNames
- Other: non invasive ventilation (NIV)
Primary outcomes (3)
- measure
- dyspnea
- timeFrame
- 48 hours
- measure
- morphine dosage
- timeFrame
- 48 hours
- measure
- Quality of Life
- timeFrame
- 48 hours
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: Major criteria for enrollment into the study were one of the following: * PaO2/FiO2 ratio \< 250 + one of the two following: * dyspnea with recruitment of the accessory muscles and/or abdominal muscles recruitment; and * respiratory rate \> 30 b/ min. Hypercapnia per se is not a criteria of inclusion, but it is not an exclusion criteria if chronic. Exclusion Criteria: * Potentially reversible causes of exacerbation such as (CPE, pneumonia or exacerbation of chronic pulmonary disorders) coma * Refusal of treatment * Inability to protect the airways * An agitated or uncooperative patient * Anatomical abnormalities interfering with mask fit * Uncontrolled cardiac ischemia or arrhythmias * Failure of more than two organs
References
Publications (1)
- DERIVEDNava S, Ferrer M, Esquinas A, Scala R, Groff P, Cosentini R, Guido D, Lin CH, Cuomo AM, Grassi M. Palliative use of non-invasive ventilation in end-of-life patients with solid tumours: a randomised feasibility trial. Lancet Oncol. 2013 Mar;14(3):219-27. doi: 10.1016/S1470-2045(13)70009-3. Epub 2013 Feb 11. PMID 23406914