DyspneaPhase 2/3NCT00053846
Buspirone in Reducing Shortness of Breath in Patients With Cancer
A Phase 2/3 study testing buspirone hydrochloride in people with Dyspnea and Pulmonary Complications, run by University of Rochester at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Dyspnea, Pulmonary Complications, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- buspirone hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 432 participants
- Where
- 15 sitesUnited States
- Study dates
- Nov 2002to Jan 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
CCOP - Dayton
Dayton, Ohio, 45429
CCOP - Central Illinois
Decatur, Illinois, 62526
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057
CCOP - Evanston
Evanston, Illinois, 60201
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479
CCOP - Greenville
Greenville, South Carolina, 29615
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Kansas City
Kansas City, Missouri, 64131
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
CCOP - Northwest
Tacoma, Washington, 98405-0986
CCOP - Wichita
Wichita, Kansas, 67214-3882
About this study
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.
Read the 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.
- Being tested
- buspirone hydrochloride, Placebo
- Keywords
- dyspnea, pulmonary complications, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buspirone hydrochlorideDrug
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
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| buspirone hydrochloride | Experimental | buspirone hydrochloride Receives: Drug: buspirone hydrochloride |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days after beginning study drug or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study startNov 2002
- Primary completionNov 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Gary Morrow, University of Rochester
- Investigators
- Peter Bushunow, MD, Study chair, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053846
- Sponsor's protocol ID
- CDR0000269487
- Other IDs
- U10CA037420, URCC U1701
- Status last verified
- Oct 2015
- First submitted
- 5 Feb 2003
- Last updated
- 24 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buspirone in Reducing Shortness of Breath in Patients With Cancer
- ClinicalTrials.gov ID
- NCT00053846
- Acronym / sponsor ID
- CDR0000269487
- Keywords
- dyspnea, pulmonary complications, unspecified adult solid tumor, protocol specific
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2002
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Feb 2003 (estimated)
- Results
- Posted 20 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| buspirone hydrochloride | Experimental | Drug: buspirone hydrochloridebuspirone hydrochloride |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| buspirone hydrochlorideThe 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 | Drug | buspirone hydrochloride |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Dyspnea as Measured by Oxygen Cost Diagram (OCD)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bushunow, MD study chair
University of Rochester
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing buspirone hydrochloride in people with Dyspnea and Pulmonary Complications, run by University of Rochester at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea as Measured by Oxygen Cost Diagram (OCD) (time frame: 28 days after beginning study drug or placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2015.