December 10 2021
Despite preliminary supporting evidence that the dopaminergic agent bupropion might improve sexual desire for female cancer survivors, the NRG Oncology CC004 clinical trial determined that bupropion did not improve outcomes when compared to a placebo. Though the results of this trial were negative, this study supports the urgent need to find effective treatment solutions for the large population of women who are concerned about side effects to their sexual desire following their cancer therapy. These results were published in the Journal of Clinical Oncology.
NRG-CC004 compared two dose-levels of extended-release bupropion in postmenopausal women who were diagnosed with breast or gynecologic cancer and completed their cancer treatment, but who had low baseline sexual desire scores (<3.3, out of a maximal score of 5) as determined by the desire subscale of the Female Sexual Function Index (FSFI). Women who participated on the trial were randomly assigned to receive either bupropion at 150 mg, bupropion at 300 mg, or placebo for 9 weeks. The loss of sexual desire in women who were treated for breast or gynecologic cancers is thought to be a response to one of two potential occurrences that are both related to dopamine insufficiency: estrogen deprivation or generalized inflammation. As a dopaminergic agent, various research suggests that bupropion might be an appropriate treatment option for loss of sexual desire, but NRG-CC004 exhibited no improvement from use of the agent.
“Cancer treatment can have a significant negative impact on female sexual function and is a common concern of female cancer survivors. Cancer survivors are expected to grow in population over the course of the next decade and over half of this population will be female,” stated Debra Barton, RN, PhD, of the University of Michigan School of Nursing and the lead author of the NRG-CC004 manuscript. “It is crucial that we continue to fund and support further research on the underlying characteristics of decreases in sexual health for these women and develop effective treatment options to improve their quality of life following treatment.”
NRG-CC004 evaluated 230 eligible women following 9 weeks of bupropion or placebo. At 9 weeks, there was no statistically significant difference in change in the desire subscale scores among treatment groups. Participants in all three arms reported improvement and the mean changes for each arm were: placebo 0.62 (SD=1.18), 150 mg 0.64 (SD=0.95) and 300 mg 0.60 (SD=0.89). Total and subscale scores on the FSFI were low throughout the study, indicating dysfunction in all groups. Additionally, there were no grade 4 or 5 adverse events (AE) related to treatment, but in the 150 mg bupropion arm, 2 patients experienced a grade 3 AE (insomnia and headache)and one patient each in the 300 mg bupropion and the placebo arms experienced a grade 3 AE (hypertension and headache, respectively).
This project was supported by UG1CA189867 (NCORP) from the National Cancer Institute (NCI) and the Breast Cancer Research Foundation (BCRF).
Barton DL, Pugh SL, Ganz PA, Plaxe SC, Koontz BF, Carter J, Greyz-Yusupov N, Page SJ, Rowland KM Jr, Balcueva EP, Nabeel S, Basil JB, Hill ML, Muller CY, Bell MC, Deshmukh S, Kachnic LA. Randomized Controlled Phase II Evaluation of Two Dose Levels of Bupropion Versus Placebo for Sexual Desire in Female Cancer Survivors: NRG-CC004. J Clin Oncol. 2021 Dec 9:JCO2101473. doi: 10.1200/JCO.21.01473. Epub ahead of print. PMID: 34882500.
About NRG Oncology
NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research of the legacy National Surgical Adjuvant Breast and Bowel Project (NSABP), Radiation Therapy Oncology Group (RTOG), and Gynecologic Oncology Group (GOG) programs. The research network seeks to carry out clinical trials with emphases on gender-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology’s extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI’s National Clinical Trials Network.