CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 432 enrolled
Drug / intervention
buspirone hydrochloride +1 moredrug
Likely dose
Buspirone hydrochloride 10 mg by mouth at bedtime for 3 days, then twice daily (morning and bedtime) for remainder of 28-day study periodAI-extracted
Key inclusion· 6
  • ✓Diagnosis of cancer
  • ✓Scheduled to receive at least 2 courses of chemotherapy (may have had prior chemotherapy)
  • ✓Grade 2 or higher dyspnea on Modified Medical Research Council Dyspnea Scale within past 5 days
  • ✓All underlying causes of dyspnea have received appropriate medical treatment
Key exclusion· 7
  • ✕History of mania or seizures
  • ✕Prior hospitalization for any psychiatric condition
  • ✕Prior hypersensitivity to buspirone
  • ✕Unable to swallow medication

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00053846
NCT00053846Phase 3Completed
CompareCT.gov

Buspirone in Reducing Shortness of Breath in Patients With Cancer

University of Rochester·interventional·Posted Feb 6, 2003·Updated Nov 24, 2015

In Brief

A Phase 3 clinical trial evaluating buspirone hydrochloride and Placebo for Dyspnea and 2 related conditions. Completed, enrolled 432 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyspnea, Pulmonary Complications, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2003
Enrollment StartNov 1, 2002
Primary CompletionNov 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 23.4 years ago

Interventions

buspirone hydrochloridedrug

The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period

Placebodrug

Placebo