Anita R Peoples1, Peter W Bushunow2, Sheila N Garland3,4, Charles E Heckler5, Joseph A Roscoe5, Luke L Peppone5, Deborah J Dudgeon6, Jeffrey J Kirshner7, Tarit K Banerjee8, Judith O Hopkins9, Shaker R Dakhil10, Marie A Flannery5, Gary R Morrow5. 1. University of Rochester Cancer Center Community Clinical Oncology Program Research Base, Behavioral Medicine Unit, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642, USA. anita_peoples@urmc.rochester.edu. 2. Lipson Cancer Center, Rochester General Hospital, 1425 Portland Avenue, Rochester, NY, 14621, USA. 3. Department of Family Medicine and Community Health, University of Pennsylvania, Philadelphia, PA, USA. 4. Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA. 5. University of Rochester Cancer Center Community Clinical Oncology Program Research Base, Behavioral Medicine Unit, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642, USA. 6. Palliative Care Medicine, Department of Internal Medicine, Queen's University, Kingston, ON, Canada. 7. HOACNY CCOP, 5008 Brittonfield Parkway, Suite #700, PO Box 2050, East Syracuse, NY, 13057, USA. 8. Marshfield CCOP, Marshfield Clinic, 1000 N. Oak Avenue, 2R-1 Lawton Center, Marshfield, WI, 54449, USA. 9. Southeast Cancer Control consortium, 2150 Country Club Road, Suite 200, Winston-Salem, NC, 27104, USA. 10. Wichita CCOP, 929 North St. Frances, Wichita, KS, 67214, USA.
Abstract
PURPOSE: Cancer-related dyspnea is a common, distressing, and difficult-to-manage symptom in cancer patients, resulting in diminished quality of life and poor prognosis. Buspirone, a non-benzodiazepine anxiolytic which does not suppress respiration and has proven efficacy in the treatment of generalized anxiety disorder, has been suggested to relieve the sensation of dyspnea in patients with COPD. The main objective of our study was to evaluate whether buspirone alleviates dyspnea in cancer patients. METHODS: We report on a randomized, placebo-controlled trial of 432 patients (mean age 64, female 51%, lung cancer 62%) from 16 participating Community Clinical Oncology Program (CCOP) sites with grade 2 or higher dyspnea, as assessed by the Modified Medical Research Council Dyspnea Scale. Dyspnea was assessed by the Oxygen Cost Diagram (OCD; higher scores are better) and anxiety by the state subscale of the State-Trait Anxiety Inventory (STAI-S; lower scores are better) at baseline and after the 4-week intervention (post-intervention). RESULTS:Mean scores from baseline to post-intervention for buspirone were OCD 8.7 to 9.0 and STAI-S 40.5 to 40.1 and for placebo were OCD 8.4 to 9.3 and STAI-S 40.9 to 38.6 with raw improvements over time on both measures being greater in the placebo group. Analysis of covariance (ANCOVA) controlling for baseline scores showed no statistically significant difference between groups for OCD (P = 0.052) or STAI-S (P = 0.062). CONCLUSION:Buspirone did not result in significant improvement in dyspnea or anxiety in cancer patients. Thus, buspirone should not be recommended as a pharmacological option for dyspnea in cancer patients.
RCT Entities:
PURPOSE:Cancer-related dyspnea is a common, distressing, and difficult-to-manage symptom in cancerpatients, resulting in diminished quality of life and poor prognosis. Buspirone, a non-benzodiazepine anxiolytic which does not suppress respiration and has proven efficacy in the treatment of generalized anxiety disorder, has been suggested to relieve the sensation of dyspnea in patients with COPD. The main objective of our study was to evaluate whether buspirone alleviates dyspnea in cancerpatients. METHODS: We report on a randomized, placebo-controlled trial of 432 patients (mean age 64, female 51%, lung cancer 62%) from 16 participating Community Clinical Oncology Program (CCOP) sites with grade 2 or higher dyspnea, as assessed by the Modified Medical Research Council Dyspnea Scale. Dyspnea was assessed by the Oxygen Cost Diagram (OCD; higher scores are better) and anxiety by the state subscale of the State-Trait Anxiety Inventory (STAI-S; lower scores are better) at baseline and after the 4-week intervention (post-intervention). RESULTS: Mean scores from baseline to post-intervention for buspirone were OCD 8.7 to 9.0 and STAI-S 40.5 to 40.1 and for placebo were OCD 8.4 to 9.3 and STAI-S 40.9 to 38.6 with raw improvements over time on both measures being greater in the placebo group. Analysis of covariance (ANCOVA) controlling for baseline scores showed no statistically significant difference between groups for OCD (P = 0.052) or STAI-S (P = 0.062). CONCLUSION:Buspirone did not result in significant improvement in dyspnea or anxiety in cancerpatients. Thus, buspirone should not be recommended as a pharmacological option for dyspnea in cancerpatients.
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