Dyspnea, Pulmonary Complications, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
dyspnea, pulmonary complications, unspecified adult solid tumor, protocol specific
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.
Interventions
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
DRUGPlacebo
Placebo
Sponsors
National Cancer Institute (NCI)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Buspirone Hydrochloride 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 | 187 |
| Placebo Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period. | 192 |
| Total | 379 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Became ineligible | 3 | 1 |
| Overall Study | Became too ill | 8 | 7 |
| Overall Study | Changed mind | 8 | 13 |
| Overall Study | Did not return data | 1 | 2 |
| Overall Study | Expired | 5 | 0 |
| Overall Study | Pills too large | 0 | 1 |
| Overall Study | Quit due to side effects | 1 | 3 |
Baseline characteristics
| Characteristic | Buspirone Hydrochloride | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 10.3 | 63.5 years STANDARD_DEVIATION 9.9 | 64.0 years STANDARD_DEVIATION 9.4 |
| Education Beyond High School | 76 participants | 154 participants | 78 participants |
| Education High School or Less | 111 participants | 225 participants | 114 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 181 Participants | 370 Participants | 189 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 7 Participants | 1 Participants |
| History of chronic obstructive pulmonary disease (COPD) No | 159 participants | 282 participants | 123 participants |
| History of chronic obstructive pulmonary disease (COPD) Yes | 28 participants | 97 participants | 69 participants |
| Marital Status Married | 127 participants | 253 participants | 126 participants |
| Marital Status Not Married | 60 participants | 126 participants | 66 participants |
| Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade 0 | 4 participants | 6 participants | 2 participants |
| Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade 1 | 21 participants | 44 participants | 23 participants |
| Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade 2 | 77 participants | 157 participants | 80 participants |
| Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade 3 | 61 participants | 115 participants | 54 participants |
| Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade 4 | 22 participants | 54 participants | 32 participants |
| Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade Unknown | 2 participants | 3 participants | 1 participants |
| O2 Cost Diagram (OCD) | 8.70 units on a scale STANDARD_DEVIATION 2.6 | 8.56 units on a scale STANDARD_DEVIATION 2.6 | 8.43 units on a scale STANDARD_DEVIATION 2.6 |
| Race/Ethnicity, Customized African American | 19 participants | 39 participants | 20 participants |
| Race/Ethnicity, Customized Other | 2 participants | 3 participants | 1 participants |
| Race/Ethnicity, Customized White | 166 participants | 337 participants | 171 participants |
| Sex: Female, Male Female | 100 Participants | 195 Participants | 95 Participants |
| Sex: Female, Male Male | 87 Participants | 184 Participants | 97 Participants |
| Tumor Site Breast | 25 participants | 52 participants | 27 participants |
| Tumor Site Gastrointestinal | 18 participants | 35 participants | 17 participants |
| Tumor Site Lung | 114 participants | 232 participants | 118 participants |
| Tumor Site Other | 30 participants | 60 participants | 30 participants |
| Tumor Stage I | 10 participants | 22 participants | 12 participants |
| Tumor Stage II | 17 participants | 35 participants | 18 participants |
| Tumor Stage III | 49 participants | 102 participants | 53 participants |
| Tumor Stage IV | 103 participants | 205 participants | 102 participants |
| Tumor Stage Unknown | 8 participants | 15 participants | 7 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 213 | 10 / 219 |
| serious Total, serious adverse events | 3 / 213 | 3 / 219 |
Outcome results
Primary
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.
Time frame: 28 days after beginning study drug or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buspirone Hydrochloride | Dyspnea as Measured by Oxygen Cost Diagram (OCD) | 8.98 units on a scale | Standard Deviation 2.85 |
| Placebo | Dyspnea as Measured by Oxygen Cost Diagram (OCD) | 9.32 units on a scale | Standard Deviation 2.62 |
Comparison: H0: The true difference in means is equal to zero. Ha: The true difference in means is not equal to zero.p-value: 0.0895% CI: [-1.02, 0.0576]ANCOVA