Clinical trial · Observational
Breathlessness Patterns in Patients With Cancer, COPD and Heart Failure: an fMRI Feasibility Study
- 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)
Dyspnea that persists despite optimal pathophysiological treatment is defined as persistent dyspnea. Currently all brain functional magnetic resonance imaging (fMRI) studies conducted to evaluate breathlessness have done so using healthy volunteers or have concentrated on acute breathlessness. Little is known about chronic breathlessness patterns and their modulation by different triggers. Furthermore, it is currently assumed in the palliative care literature that patients suffering from different advanced and progressive diseases such as cancer, heart failure (HF) or chronic obstructive pulmonary disease (COPD) have the same triggers, perceptions and neurological pathways and thus require the same treatments/interventions (i.e. opioids as first line symptomatic pharmacologic treatment). However, it is now known that patients belonging to different disease groups do not necessarily benefit from opioids. Aim of the study To assess the feasibility of identifying dyspnea patterns in different life-limiting conditions and to evaluate the effect of immersive virtual reality (IVR) on dyspnea using patient-reported-outcomes (PROMs). Study procedure: Patients with advanced chronic diseases such as cancer, COPD or HF suffering from dyspnea will undergo a brain fMRI in combination with an IVR intervention. The fMRI data will be reviewed to identify different patterns of dyspnea and the effect of IVR on dyspnea will be assessed through PROMs. Patients will be asked about the perceived burden of the study.
Conditions
Conditions (4)
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 |
| Chronic Obstructive Pulmonary Disease (COPD) | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Volunteers | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cerebral fMRI | Other | — | UNRESOLVED |
| Immersive virtual reality | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants
- description
- Patients and healthy volunteers who will have a cerebral fMRI
- interventionNames
- Other: Cerebral fMRI
- Other: Immersive virtual reality
Primary outcomes (1)
- measure
- Feasibility of the study
- timeFrame
- 18 months after the beginning of the study
- description
- Composite outcomes: 1. Recruitment rate: proportion of eligible patients who consent to participate, calculated as the number of participants enrolled divided by the total number of eligible patients approached during the recruitment period. A recruitment rate ≥ 50% will be considered feasible. 2. Retention rate: proportion of enrolled participants who complete the planned intervention (fMRI, vital signs, and study-associated questionnaires). A retention rate ≥ 70% will be considered acceptable. If both thresholds are met (recruitment rate and retention rate), progression to a larger observational study will be considered.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Age ≥ 18 years and * Followed by the outpatient palliative care clinic of the Geneva University Hospitals, Switzerland (HUG) and * Breathlessness at rest \> 2 and \< 8 on the NRS (numeric rating scale 0 to 10) and * Persistent breathlessness (persistent dyspnea for \> 3 weeks despite adequate and maximal medication according to the pathology) and * In a stable clinical condition, i.e., without an episode of acute cardiac, respiratory, and/or neurological failure leading to hospitalization in the previous 4 weeks and * Diagnosis of either HF stage NYHA III-IV, or COPD with dyspnea on the modified MRC scale grade 3-4, or oncological disease with primary or secondary pulmonary involvement Inclusion Criteria for Healthy Volunteers (Control Group) * Age ≥ 18 years and * No respiratory symptoms: dyspnea, cough, wheezing and * No known pulmonary, cardiac, or oncological disease and * Smoking status \< 10 pack-years and * No contraindication to fMRI (Appendix 3) and * Ability to lie flat (supine position) and * No diagnosed psychiatric illness (severe depression, severe anxiety, psychosis, other) or antipsychotic treatment deemed a contraindication for fMRI based on physician judgement and * No neurological disorders according to neurological assessment, including diagnosed dementia (frontotemporal dementia, Alzheimer's disease, etc.), brain pathology (tumor, stroke, Parkinson's disease, etc.), or epilepsy and * No claustrophobia, acrophobia, photophobia, severe hearing loss, and/or severe visual deficit and * No contraindication to IVR (migraines, photosensitive epilepsy, vertigo) Exclusion Criteria * Breathlessness at rest ≥ 8 on the NRS (numeric rating scale 0 to 10) * Contraindication to fMRI * Inability to lie flat (supine position) * Diagnosed psychiatric illness (severe depression, severe anxiety, psychosis, other) or antipsychotic treatment deemed a contraindication for fMRI based on physician judgement * Neurological disorders according to neurological assessment, including diagnosed dementia (frontotemporal dementia, Alzheimer's disease, etc.), brain pathology (tumor, stroke, Parkinson's disease, etc.), or epilepsy * Presence of claustrophobia, acrophobia, photophobia, severe hearing loss, and/or severe visual deficit * Contraindication to IVR (migraines, photosensitive epilepsy, vertigo)
References
Publications (17)
- BACKGROUNDTzourio-Mazoyer N, Landeau B, Papathanassiou D, Crivello F, Etard O, Delcroix N, Mazoyer B, Joliot M. Automated anatomical labeling of activations in SPM using a macroscopic anatomical parcellation of the MNI MRI single-subject brain. Neuroimage. 2002 Jan;15(1):273-89. doi: 10.1006/nimg.2001.0978. PMID 11771995
- BACKGROUNDSmallwood NE, Pascoe A, Wijsenbeek M, Russell AM, Holland AE, Romero L, Ekstrom M. Opioids for the palliation of symptoms in people with serious respiratory illness: a systematic review and meta-analysis. Eur Respir Rev. 2024 Oct 9;33(174):230265. doi: 10.1183/16000617.0265-2023. Print 2024 Oct. PMID 39384304
- BACKGROUNDEkstrom M, Ferreira D, Chang S, Louw S, Johnson MJ, Eckert DJ, Fazekas B, Clark KJ, Agar MR, Currow DC; Australian National Palliative Care Clinical Studies Collaborative. Effect of Regular, Low-Dose, Extended-release Morphine on Chronic Breathlessness in Chronic Obstructive Pulmonary Disease: The BEAMS Randomized Clinical Trial. JAMA. 2022 Nov 22;328(20):2022-2032. doi: 10.1001/jama.2022.20206. PMID 36413230
- BACKGROUNDFinnegan SL, Browning M, Duff E, Harmer CJ, Reinecke A, Rahman NM, Pattinson KTS. Brain activity measured by functional brain imaging predicts breathlessness improvement during pulmonary rehabilitation. Thorax. 2023 Sep;78(9):852-859. doi: 10.1136/thorax-2022-218754. Epub 2022 Dec 26. PMID 36572534
- BACKGROUNDYu L, De Mazancourt M, Hess A, Ashadi FR, Klein I, Mal H, Courbage M, Mangin L. Functional connectivity and information flow of the respiratory neural network in chronic obstructive pulmonary disease. Hum Brain Mapp. 2016 Aug;37(8):2736-54. doi: 10.1002/hbm.23205. Epub 2016 Apr 5. PMID 27059277
- BACKGROUNDNakarada-Kordic I, Reay S, Bennett G, Kruse J, Lydon AM, Sim J. Can virtual reality simulation prepare patients for an MRI experience? Radiography (Lond). 2020 Aug;26(3):205-213. doi: 10.1016/j.radi.2019.11.004. Epub 2019 Nov 28.