Aromatase Inhibitors + Bupropion for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether adding Bupropion XL, a medication typically used for depression and smoking cessation, can improve sexual desire in women with early-stage breast cancer who are on aromatase inhibitor therapy and experiencing hypoactive sexual desire disorder (HSDD). HSDD can cause distress due to a lack of interest in sexual activities. The study tests different treatment combinations to determine the most effective approach. Women with early-stage breast cancer, on aromatase inhibitors, and experiencing persistent low sexual desire may be eligible to join. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works and measuring its effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that Bupropion Extended Release (XL) is generally well-tolerated. The FDA has approved Bupropion, an antidepressant, for treating major depression, seasonal depression, and aiding smoking cessation. Studies have also explored its potential to improve sexual function and reduce tiredness in cancer patients.
In studies on cancer-related tiredness, Bupropion proved safe and effective. Specifically, research demonstrated that patients experienced less fatigue without major side effects. Another study examined sexual function in women undergoing cancer treatment and found improvements with Bupropion.
Although Bupropion is often used for other conditions, it hasn't been thoroughly tested in women with early-stage breast cancer who are also taking aromatase inhibitors. However, existing research supports its safety in similar groups.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using Bupropion alongside aromatase inhibitors for breast cancer because it offers a novel approach to managing Hypoactive Sexual Desire Disorder (HSDD) in patients. While standard treatments include aromatase inhibitors and GnRH agonists, which focus on hormone suppression, Bupropion introduces a new element by potentially alleviating HSDD symptoms, a common side effect of these therapies. Bupropion is an antidepressant that works on neurotransmitters in the brain, providing a unique mechanism that could enhance quality of life for patients experiencing sexual side effects. By combining Bupropion with traditional hormone therapies, this approach aims to improve both cancer treatment and patient well-being.
What evidence suggests that this trial's treatments could be effective for improving sexual functioning in women with early-stage breast cancer?
This trial will evaluate the use of Bupropion XL combined with aromatase inhibitors for women with breast cancer. Studies have shown mixed results regarding Bupropion XL's ability to boost sexual desire in these women. One study found that Bupropion might improve sexual function in women undergoing breast cancer treatment. However, another study suggested that Bupropion does not significantly increase sexual desire for female cancer survivors. Bupropion affects dopamine and norepinephrine, brain chemicals related to mood and desire. While promising signs exist, more research is needed to confirm its effectiveness for this specific group.13467
Who Is on the Research Team?
Oana Danciu, MD
Principal Investigator
University of Illinois at Chicago
Are You a Good Fit for This Trial?
This trial is for women with early-stage, hormone receptor positive breast cancer who are taking aromatase inhibitors and experiencing low sexual desire that causes distress. Participants must not have other major health issues that would prevent them from joining.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive aromatase inhibitor therapy, with some receiving additional bupropion and/or ovarian suppression therapy. Treatment adjustments are made based on HSDD diagnosis.
Follow-up
Participants are monitored for safety, effectiveness, and disease progression after treatment
Extension/Long-term follow-up
Participants continue to be monitored for overall survival and disease-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Bupropion Extended Release (XL)
Trial Overview
The study tests if adding Bupropion XL to ongoing aromatase inhibitor therapy can improve sexual desire in these women. The effect will be measured using a questionnaire about sexual functioning.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Participants will receive aromatase inhibitor as part of standard of care for early stage breast cancer plus bupropion 150 mg orally twice daily. The duration of AI therapy will be at the discretion of the investigator. Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa). Patients with Hypoactive Sexual Desire Disorder will also have the option to change their dose to 300 mg orally once a day. Those who are pre-menopausal will also be treated with ovarian suppression therapy (in the form of a GnRH agonist) per standard of care. They will be treated by subcutaneous injection every 28 days and the type, duration, and dose of drug will be per the treating physician's discretion.
Participants will receive aromatase inhibitor as part of standard of care for early stage breast cancer plus bupropion 150 mg orally twice daily. The duration of AI therapy will be at the discretion of the investigator. Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa). Patients with Hypoactive Sexual Desire Disorder will also have the option to change their dose to 300 mg orally once a day.
Participants will receive aromatase inhibitor as part of standard of care for early stage breast cancer. The duration of AI therapy will be at the discretion of the investigator. Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa). Those who are pre-menopausal will also be treated with ovarian suppression therapy (in the form of a GnRH agonist) per standard of care. They will be treated by subcutaneous injection every 28 days and the type, duration, and dose of drug will be per the treating physician's discretion. Those who have ongoing Hypoactive Sexual Desire Disorder symptoms have the option to crossover to the bupropion arm.
Participants will receive aromatase inhibitor as part of standard of care for early stage breast cancer. The duration of AI therapy will be at the discretion of the investigator. Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa). Those who have ongoing Hypoactive Sexual Desire Disorder symptoms have the option to crossover to the bupropion arm.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Illinois at Chicago
Lead Sponsor
Citations
Wellbutrin XL, Major Depressive Disorder and Breast Cancer
The study will determine whether or not bupropion extended release (Wellbutrin XLTM) is useful in lessening the symptoms of depression in women with breast ...
Bupropion XL and SR Have Similar Effectiveness and ... - PMC
We found that bupropion XL is likely therapeutically equivalent to bupropion SR when treating smoking among cancer patients, and produces similar side effects.
An open-label, fixed-dose study of bupropion effect on ...
In this non-controlled open trial bupropion 150 mg/daily was associated with improved sexual function in women receiving adjuvant systemic treatment for breast ...
4.
nrgoncology.org
nrgoncology.org/Home/News/Post/bupropion-does-not-improve-sexual-desire-for-female-cancer-survivors-on-nrg-oncology-clinical-study/Bupropion Does Not Improve Sexual Desire for Female ...
Despite preliminary supporting evidence that the dopaminergic agent bupropion might improve sexual desire for female cancer survivors, the NRG ...
An open-label, fixed-dose study of bupropion effect on ...
The data presented in this small non-controlled open trial suggest that bupropion may improve sexual function in women with breast cancer experiencing sexual ...
A Randomized Placebo-Controlled Trial of Bupropion for ...
A randomized, double-blind, placebo-controlled trial will examine the effects of bupropion on cancer-related fatigue.
Efficacy and safety of bupropion in cancer-related fatigue, a ...
The results showed that the more approaching to the end of study, the more effective bupropion gets and the mean scores of patients received ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.