Buspirone in Reducing Shortness of Breath in Patients With Cancer

University of Rochester

Status and phase

Completed

Phase 3

Phase 2

Conditions

Dyspnea

Unspecified Adult Solid Tumor, Protocol Specific

Pulmonary Complications

Treatments

Drug: Placebo

Drug: buspirone hydrochloride

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00053846

URCC U1701 (Other Identifier)

U10CA037420 (U.S. NIH Grant/Contract)

CDR0000269487

Details and patient eligibility

About

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.

Full 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.

Enrollment

432 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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