Buspirone in Reducing Shortness of Breath in Patients With Cancer

NCT00053846 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000269487U10CA037420URCC U1701
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 15

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.

Conditions

Dyspnea; Pulmonary Complications; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

dyspnea; pulmonary complications; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

buspirone hydrochloride

EXPERIMENTAL

buspirone hydrochloride

Drug: buspirone hydrochloride

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

buspirone hydrochloride DRUG

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

buspirone hydrochloride

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (15)

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612-7323, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

Dyspnea

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Results Point of Contact

• Title: Charles E. Heckler, PhD, MS. Research Assistant Professor
• Organization: University of Rochester Medical Center

checkler@urmc.rochester.edu

585-273-1141

Study Officials

• Peter Bushunow, MD

  University of Rochester

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, URCC CCOP Research Base

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: November 1, 2002
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2011
• Last Updated: November 24, 2015
• Results First Posted: March 20, 2015

Record last verified: 2015-10

Locations

US (15)