Clinical trial · Interventional
Buspirone in Reducing Shortness of Breath in Patients With Cancer
NCT00053846CI-TRIAL-00019930completedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Buspirone may be effective in reducing dyspnea (shortness of breath) in patients with cancer who are undergoing chemotherapy. PURPOSE: Randomized clinical trial to study the effectiveness of buspirone in reducing shortness of breath in patients who are undergoing chemotherapy for cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dyspnea | — | UNRESOLVED | — |
| Pulmonary Complications | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| buspirone hydrochloride | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- buspirone hydrochloride
- description
- buspirone hydrochloride
- interventionNames
- Drug: buspirone hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Dyspnea as Measured by Oxygen Cost Diagram (OCD)
- timeFrame
- 28 days after beginning study drug or placebo
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of cancer
* Treatment includes the following scenarios:
* May have had prior chemotherapy course(s)
* Scheduled to receive at least 2 courses of chemotherapy
* Courses may include multiple treatment days such as days 1-5 or day 1-day 8 regimens and may include oral regimens
* Dyspnea as a symptom within the past 5 days (defined by a score of at least grade 2 on the Modified Medical Research Council Dyspnea Scale)
* All underlying causes of dyspnea have received medical treatment per best clinical judgement of treating physician
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Eastern Cooperative Oncology Group 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Adequate hepatic function (determined by treating oncologist)
Renal
* Adequate renal function (determined by treating oncologist)
Cardiovascular
* Adequate cardiac function (determined by treating oncologist)
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No history of mania or seizures
* No prior hospitalization for any psychiatric condition
* No prior hypersensitivity to buspirone
* Able to swallow medication
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Concurrent radiotherapy allowed
Surgery
* Not specified
Other
* At least 2 weeks since prior and no concurrent monoamine oxidase inhibitors (MAOIs)
* Concurrent narcotic medications allowed
* Concurrent benzodiazepine medications allowed
* Concurrent serotonin reuptake inhibitors allowed
* No concurrent alcoholReferences
Publications (0)
Data not yet available
No reference posted for this study.