Randomized Controlled Phase II Evaluation of Two Dose Levels of Bupropion Versus Placebo for Sexual Desire in Female Cancer Survivors: NRG-CC004

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.

Trial registration: ClinicalTrials.gov NCT03180294.

Conflict of interest statement

Debra L. BartonResearch Funding: Merck Stephanie L. PughResearch Funding: Pfizer (Inst), Millennium (Inst) Patricia A. GanzLeadership: Intrinsic LifeSciences (I)Stock and Other Ownership Interests: Xenon Pharma (I), Intrinsic LifeSciences (I), Teva, Novartis, Merck, Johnson & Johnson, Pfizer, GlaxoSmithKline, Abbott LaboratoriesConsulting or Advisory Role: InformedDNA, Vifor Pharma (I), Ambys Medicines (I), Global Blood Therapeutics (I), GlaxoSmithKline (I), Ionis Pharmaceuticals (I), Protagonist Therapeutics (I), Akebia Therapeutics (I), Regeneron (I), Sierra Oncology (I), Rockwell Medical Technologies Inc (I), Astellas Pharma (I), Gossamer Bio (I), American Regent (I), Disc Medicine (I), Blue Note Therapeutics (I), Grail (I)Research Funding: Blue Note Therapeutics (Inst)Patents, Royalties, Other Intellectual Property: Related to iron metabolism and the anemia of chronic disease, UpToDate royalties for section editor on survivorshipTravel, Accommodations, Expenses: Intrinsic LifeSciences (I) Steven C. PlaxeStock and Other Ownership Interests: Pfizer, Merck, Zimmer Biomet, GlaxoSmithKline, AstraZeneca, Bristol Myers Squibb/Pfizer, Johnson & Johnson/JanssenResearch Funding: Endocyte, Incyte, MedImmune, Novartis, Pfizer, Janssen Oncology, BIND Therapeutics, PharmaMar, AstraZeneca, Kevelt, Millennium, Tesaro Bridget F. KoontzEmployment: GenesisCareLeadership: GenesisCareConsulting or Advisory Role: Blue Earth Diagnostics, Myovant Sciences, Rythera TherapeuticsResearch Funding: Janssen, Merck, Blue Earth DiagnosticsPatents, Royalties, Other Intellectual Property: Demos Publishing Matthew L. HillStock and Other Ownership Interests: AstraZeneca, Newlink Genetics, Kazia Therapeutics, Leap Therapeutics, OncoSec, MEI Pharma, PLx Pharma, Radius Health, Crispr Therapeutics, Cassava SciencesOpen Payments Link: https://openpaymentsdata.cms.gov/physician/820072 Carolyn Y. MullerResearch Funding: AstraZeneca, Genmab, VBL Therapeutics, Roche/Genentech, TapImmune Inc, Linnaeus Therapeutics, Agenus, Incyte, MerckPatents, Royalties, Other Intellectual Property: Have a pending patent on the cancer use for R-ketorolac—not yet its own new drugOther Relationship: NCI, Department of Defense Lisa A. KachnicConsulting or Advisory Role: New B InnovationResearch Funding: Varian Medical SystemsPatents, Royalties, Other Intellectual Property: UpToDateNo other potential conflicts of interest were reported.

Figures

FIG 1.

CONSORT diagram. FSFI, Female Sexual Function Index.

FIG 2.

(A) FSFI mean desire score over time (higher is better). (B) FSFI mean total score over time (higher is better). FSFI, Female Sexual Function Index.

FIG 3.

(A) PROMIS sexual interest mean change scores at 5 and 9 weeks (higher is better). (B) PROMIS global sexual satisfaction mean change scores at 5 and 9 weeks (higher is better). (C) Fatigue mean change score at 5 and 9 weeks (negative change scores indicate improved fatigue).