Debra L Barton1, Stephanie L Pugh2, Patricia A Ganz3, Steven C Plaxe4, Bridget F Koontz5, Jeanne Carter6, Natalya Greyz-Yusupov7, Seth J Page8, Kendrith M Rowland9, Ernie P Balcueva10, Sobia Nabeel11, Jack B Basil12, Matthew L Hill13, Carolyn Y Muller14, Maria C Bell15, Snehal Deshmukh2, Lisa A Kachnic16. 1. University of Michigan School of Nursing, Ann Arbor, MI. 2. NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, PA. 3. UCLA-Jonsson Comprehensive Cancer Center, Los Angeles, CA. 4. UC San Diego Moores Cancer Center, LaJolla, CA. 5. Duke University Medical Center, Durham, NC. 6. Memorial Sloan Kettering Cancer Center, New York, NY. 7. Kaiser Permanente-San Rafael, San Rafael, CA. 8. Wichita CCOP, Wichita, KS. 9. Carle Cancer Center, Urbana, IL. 10. Ascension Michigan St Marys Hospital, Saginaw, MI accrual under Michigan Cancer Research Consortium NCORP. 11. University of Oklahoma Health Sciences Center, Oklahoma City, OK. 12. Bethesda North Hospital, Cincinnati, OH accrual under Catholic Health Initiatives NCORP. 13. Medical Oncology and Hematology Associates-Des Moines, Des Moines, IA accrual under Iowa-Wide Oncology Research Coalition NCORP. 14. University of New Mexico Cancer Center, Albuquerque, NM accrual under New Mexico Minority Underserved NCORP. 15. Sanford Health, Sioux Falls, SD accrual under Sanford NCI Community Oncology Research Program of the North Central Plains. 16. NYP-Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, NY.
Abstract
PURPOSE: Because of the negative impact of cancer treatment on female sexual function, effective treatments are warranted. The purpose of this multisite study was to evaluate the ability of two dose levels of extended-release bupropion, a dopaminergic agent, to improve sexual desire more than placebo at 9 weeks, measured by the desire subscale of the Female Sexual Function Index (FSFI), and to evaluate associated toxicities. METHODS: Postmenopausal women diagnosed with breast or gynecologic cancer and low baseline FSFI desire scores (< 3.3), who had completed definitive cancer therapy, were eligible. Women were randomly assigned to receive 150 mg or 300 mg once daily of extended-release bupropion or a matching placebo. t-tests were performed on the FSFI desire subscale to evaluate whether there was a significantly greater change from baseline to 9 weeks between placebo and each bupropion arm as the primary end point. Sixty-two patients per arm provided 80% power using a one-sided t-test. RESULTS: Two hundred thirty women were randomly assigned from 72 institutions through the NRG Oncology NCORP network. At 9 weeks, there were no statistically significant differences in change of the desire subscale scores between groups; participants in all three arms reported improvement. The mean changes for each arm were placebo 0.62 (standard deviation [SD] = 1.18), 150-mg once daily bupropion 0.64 (SD = 0.95), and 300-mg once daily bupropion 0.60 (SD = 0.89). Total and subscale scores on the FSFI were low throughout the study, indicating dysfunction in all groups. CONCLUSION: Bupropion was not more effective than placebo in improving the desire subscale of the FSFI. Subscale and total scores of the FSFI demonstrated dysfunction throughout the 9 weeks of the study. More research is needed to support sexual function in female cancer survivors.
PURPOSE: Because of the negative impact of cancer treatment on female sexual function, effective treatments are warranted. The purpose of this multisite study was to evaluate the ability of two dose levels of extended-release bupropion, a dopaminergic agent, to improve sexual desire more than placebo at 9 weeks, measured by the desire subscale of the Female Sexual Function Index (FSFI), and to evaluate associated toxicities. METHODS: Postmenopausal women diagnosed with breast or gynecologic cancer and low baseline FSFI desire scores (< 3.3), who had completed definitive cancer therapy, were eligible. Women were randomly assigned to receive 150 mg or 300 mg once daily of extended-release bupropion or a matching placebo. t-tests were performed on the FSFI desire subscale to evaluate whether there was a significantly greater change from baseline to 9 weeks between placebo and each bupropion arm as the primary end point. Sixty-two patients per arm provided 80% power using a one-sided t-test. RESULTS: Two hundred thirty women were randomly assigned from 72 institutions through the NRG Oncology NCORP network. At 9 weeks, there were no statistically significant differences in change of the desire subscale scores between groups; participants in all three arms reported improvement. The mean changes for each arm were placebo 0.62 (standard deviation [SD] = 1.18), 150-mg once daily bupropion 0.64 (SD = 0.95), and 300-mg once daily bupropion 0.60 (SD = 0.89). Total and subscale scores on the FSFI were low throughout the study, indicating dysfunction in all groups. CONCLUSION: Bupropion was not more effective than placebo in improving the desire subscale of the FSFI. Subscale and total scores of the FSFI demonstrated dysfunction throughout the 9 weeks of the study. More research is needed to support sexual function in female cancer survivors.
Authors: John Thorp; James Simon; Dan Dattani; Leslie Taylor; Toshio Kimura; Miguel Garcia; Lynna Lesko; Robert Pyke Journal: J Sex Med Date: 2012-01-12 Impact factor: 3.802
Authors: Anita H Clayton; Harry A Croft; Joseph P Horrigan; Donna S Wightman; Alok Krishen; Nathalie E Richard; Jack G Modell Journal: J Clin Psychiatry Date: 2006-05 Impact factor: 4.384