Phase 3
N=432
Buspirone in Reducing Shortness of Breath in Patients With Cancer
Dyspnea · Pulmonary Complications · Unspecified Adult Solid Tumor, Protocol Specific
Bottom Line
View on ClinicalTrials.gov: NCT00053846 ↗Enrolled (actual)
432
Serious AEs
1.4%
Results posted
Mar 2015
Primary outcome: Primary: Dyspnea as Measured by Oxygen Cost Diagram (OCD) — 8.98; 9.32 units on a scale — p=0.080
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- buspirone hydrochloride (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dyspnea as Measured by Oxygen Cost Diagram (OCD) |
8.98; 9.32 | 0.080 |
Summary
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.
Eligibility Criteria
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 alcohol
Data sourced from ClinicalTrials.gov (NCT00053846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.