CompletedPhase 2 / Phase 3NCT00053846

Buspirone in Reducing Shortness of Breath in Patients With Cancer

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.

Checked against the public recordLast updated Nov 24, 2015 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2 / Phase 3
U.S. locations15
SponsorUniversity of Rochester
01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Phase 2 / Phase 3
Sponsor
University of Rochester
Interventions being studied
Drug: buspirone hydrochloride; Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • MBCCOP - University of Illinois at ChicagoChicago, Illinois
  • CCOP - Central IllinoisDecatur, Illinois
  • CCOP - EvanstonEvanston, Illinois
  • CCOP - WichitaWichita, Kansas
  • CCOP - KalamazooKalamazoo, Michigan
  • CCOP - Kansas CityKansas City, Missouri
  • CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada
  • CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York
  • CCOP - Southeast Cancer Control ConsortiumGoldsboro, North Carolina
  • CCOP - DaytonDayton, Ohio
  • CCOP - Columbia River Oncology ProgramPortland, Oregon
  • CCOP - GreenvilleGreenville, South Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 24, 2015. Always confirm current availability with the study team.

View original record ↗