This trial is active, not recruiting.

Conditions dyspnea, pulmonary complications, unspecified adult solid tumor, protocol specific
Treatment buspirone hydrochloride
Sponsor University of Rochester
Collaborator National Cancer Institute (NCI)
Start date November 2002
End date July 2014
Trial size 376 participants
Trial identifier NCT00053846, CDR0000269487, U10CA037420, URCC-U1701


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose supportive care
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

Primary Outcomes

time frame: 28 days after beginning study drug or placebo

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Dyspnea In Cancer Patients
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of Rochester.