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.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Dyspnea; Pulmonary Complications
• Intervention / Treatment: Drug: Placebo; Drug: buspirone hydrochloride

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 Type: Interventional
• Enrollment (Actual): 432
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612-7323
      • MBCCOP - University of Illinois at Chicago
    • Decatur, Illinois, United States, 62526
      • CCOP - Central Illinois
    • Evanston, Illinois, United States, 60201
      • CCOP - Evanston
  • Kansas
    • Wichita, Kansas, United States, 67214-3882
      • CCOP - Wichita
  • Michigan
    • Kalamazoo, Michigan, United States, 49007-3731
      • CCOP - Kalamazoo
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • CCOP - Kansas City
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Nevada Cancer Research Foundation
  • New York
    • East Syracuse, New York, United States, 13057
      • CCOP - Hematology-Oncology Associates of Central New York
  • North Carolina
    • Goldsboro, North Carolina, United States, 27534-9479
      • CCOP - Southeast Cancer Control Consortium
  • Ohio
    • Dayton, Ohio, United States, 45429
      • CCOP - Dayton
  • Oregon
    • Portland, Oregon, United States, 97225
      • CCOP - Columbia River Oncology Program
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • CCOP - Greenville
    • Spartanburg, South Carolina, United States, 29303
      • CCOP - Upstate Carolina
  • Washington
    • Tacoma, Washington, United States, 98405-0986
      • CCOP - Northwest
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • CCOP - Marshfield Clinic Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: buspirone hydrochloride	Drug: buspirone hydrochloride; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea as Measured by Oxygen Cost Diagram (OCD)	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.	28 days after beginning study drug or placebo

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Peter Bushunow, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: February 5, 2003
• First Submitted That Met QC Criteria: February 5, 2003
• First Posted (Estimate): February 6, 2003

Study Record Updates

• Last Update Posted (Estimate): November 24, 2015
• Last Update Submitted That Met QC Criteria: October 27, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific; dyspnea; pulmonary complications
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Receptor Agonists; Anti-Anxiety Agents; Buspirone
• Other Study ID Numbers: CDR0000269487; U10CA037420 (U.S. NIH Grant/Contract); URCC U1701 (Other Identifier: University of Rochester)