Using the Female Sexual Function Index (FSFI) as a measurement tool, investigators found that desire scores were not significantly different for participants who received bupropion versus a placebo over the 9-week study period.
“Sexual health is a complex phenomenon and [our results suggest that] no one intervention is going to solve the broader issue,” lead author Debra Barton RN, PhD, FAAN, professor in the School of Nursing at the University of Michigan, Ann Arbor, told Medscape Medical News.
Sexual dysfunction is common among cancer survivors and experienced across multiple cancer types and stages of disease. Research shows that as many as 70% of female cancer survivors report loss of desire compared to up to one third of the general population.
Common sexual concerns among female cancer survivors include low desire, arousal issues, lack of appropriate lubrication, difficulty in achieving orgasm, and pain with penetrative sexual activity. Additionally, these women may experience significant overlap of symptoms, and often encounter multiple sexual issues that are exacerbated by a range of cancer treatments.
“It’s a huge problem,” said Maryam B. Lustberg, MD, MPH, from Yale Cancer Center, New Haven, Connecticut, who wrote an accompanying editorial.
Despite the prevalence of sexual dysfunction among cancer survivors, effective treatments remain elusive. Preliminary evidence suggests that bupropion, already approved for seasonal affective disorder, major depressive disorder, and smoking cessation, may also enhance libido.
Barton and colleagues conducted this phase 2 trial, published online in the Journal of Clinical Oncology, to determine whether bupropion can improve sexual desire in female cancer survivors without undesirable side effects.
In the study, Barton and colleagues compared two dose levels of extended-release bupropion in a cohort of 230 postmenopausal women diagnosed with breast or gynecologic cancer and low baseline FSFI desire scores (< 3.3), who had completed definitive cancer therapy.
Participants were randomized to receive either 150 mg (79 patients) or 300 mg (74 patients) once daily of extended-release bupropion, or placebo (77 patients).
Barton and colleagues then evaluated whether sexual desire significantly improved over the 9-week study period comparing the bupropion arms and the placebo group.
Overall, the authors found no significant differences (mean between arm change for 150 mg once daily and placebo of .02, P = .93; mean between arm change for 300 mg once daily and placebo of -.02, P = .92). Mean scores at 9 weeks on the desire subscale were 2.17, 2.27, and 2.30 for 150 mg, 300 mg, and the placebo group, respectively.
In addition, none of the subscales — which included arousal, lubrication, and orgasm — or the total score showed a significant difference between arms at either 5 or 9 weeks.
Bupropion did, however, appear to be well tolerated. No grade 4 or 5 treatment-related adverse events occurred. In the 150-mg bupropion arm, 2 patients (2.6%) experienced a grade 3 event (insomnia and headache) and 1 patient in the 300-mg bupropion arm (1.4%) and placebo arm (1.3%) experienced a grade 3 event related to treatment (hypertension and headache, respectively).
In the accompanying editorial, Lustberg and colleagues “applaud the authors for conducting a study in this population of cancer survivors,” noting that “evidenced-based approaches have not been extensively studied.”
Lustberg and colleagues also commented that other randomized controlled clinical trials evaluating sexual desire disorder assessed outcomes using additional metrics, such as the Female Sexual Distress Scale-Revised questionnaire, which measures distress related to sexual dysfunction and low desire, in particular.
“The use of specific validated instruments for libido in place of the FSFI might have helped determine the effect of the study intervention in this reported trial,” they write.
Overall, according to Lustberg and colleagues, the negative results of this study indicate that a multidisciplinary clinical approach may be needed.
“As much as we would like to have one intervention that addresses this prominent issue, the evidence strongly suggests that cancer-related sexual problems may need an integrative biopsychosocial model that intervenes on biologic, psychologic, interpersonal, and social-cultural factors, not just on one factor, such as libido,” they write. “Such work may require access to multidisciplinary care with specialists in women’s health, pelvic floor rehabilitation, and psychosocial oncology.”
Barton says she has been developing a multicomponent approach to addressing sexual health in female cancer survivors.
However, she notes, “there is still much we do not fully understand about the broader impact of the degree of hormone deprivation in the population of female cancer survivors. A better understanding would provide clearer targets for interventions.”
The study was supported by the National Cancer Institute and Breast Cancer Research Foundation.
Barton has disclosed research funding from Merck. Lustberg has declared honoraria: Novartis, Biotheranostics; consulting or advisory role: PledPharma, Disarm Therapeutics, Pfizer; other relationship: Cynosure/Hologic.