Buspirone in Reducing Shortness of Breath in Patients With Cancer

Phase 2

Completed

• Conditions: Dyspnea; Pulmonary Complications; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: Placebo; Drug: buspirone hydrochloride

• Registration Number: NCT00053846
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

OBJECTIVES:

* Assess the degree to which buspirone can decrease the sensation of dyspnea in patients with malignant disease.

* Estimate the incidence of dyspnea in patients seen in community oncology practice settings.

* Investigate interrelationships of fatigue, depression, anxiety, and patient report of dyspnea.

* Assess the quality of life of patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center (CCOP site). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Beginning on day 7 of chemotherapy, patients receive oral buspirone once a day for 3 days and then twice daily for up to 28 days.

* Arm II: Patients receive oral placebo as in arm I. Dyspnea is assessed at baseline. Dyspnea, mood, fatigue, depression, anxiety, and quality of life are assessed within 5-7 days before chemotherapy and immediately following therapy.

PROJECTED ACCRUAL: A total of 376 patients (188 per treatment arm) will be accrued for this study.

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2003-02-05
• Study First Submitted QC: 2003-02-05
• Study First Posted: 2003-02-06
• Primary Completion: 2010-11
• Study Completion: 2011-01
• Results First Submitted: 2014-08-20
• Results First Submitted QC: 2015-03-12
• Results First Posted: 2015-03-20
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
buspirone hydrochloride	buspirone hydrochloride	buspirone hydrochloride

Primary Outcome Measures

Name	Time	Method
Dyspnea as Measured by Oxygen Cost Diagram (OCD)	28 days after beginning study drug or placebo	OCD was used to evaluate dyspnea on exertion and activities of daily living. OCD is a visual analog scale for quantifying a patient's evaluation of tolerance of exertion, which corresponds to oxygen requirements at different activity levels. It is measured as a score of 2 (sleeping) to 14 (brisk walking uphill). HIgher scores indicate fewer limitations due to dyspnea.

Trial Locations

Locations (15)

CCOP - Dayton; 🇺🇸 Dayton, Ohio, United States

CCOP - Southeast Cancer Control Consortium; 🇺🇸 Goldsboro, North Carolina, United States

CCOP - Central Illinois; 🇺🇸 Decatur, Illinois, United States

CCOP - Kalamazoo; 🇺🇸 Kalamazoo, Michigan, United States

CCOP - Upstate Carolina; 🇺🇸 Spartanburg, South Carolina, United States

CCOP - Nevada Cancer Research Foundation; 🇺🇸 Las Vegas, Nevada, United States

CCOP - Marshfield Clinic Research Foundation; 🇺🇸 Marshfield, Wisconsin, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

CCOP - Columbia River Oncology Program; 🇺🇸 Portland, Oregon, United States

CCOP - Evanston; 🇺🇸 Evanston, Illinois, United States

MBCCOP - University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

CCOP - Greenville; 🇺🇸 Greenville, South Carolina, United States

CCOP - Northwest; 🇺🇸 Tacoma, Washington, United States

CCOP - Hematology-Oncology Associates of Central New York; 🇺🇸 East Syracuse, New York, United States

CCOP - Kansas City; 🇺🇸 Kansas City, Missouri, United States