Breast or Gynecologic Cancer, Improving Sexual Desire (NRG-CC004)
A Phase IIR/III Trial of Standard of Care Therapy With or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer
This phase II randomized trial studies how well bupropion hydrochloride works in improving sexual desire in women with breast or gynecological cancer. Bupropion hydrochloride may work by boosting sexual desire, energy, or motivation without causing intolerable or undesirable side effects.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
Prior to Step 1 Registration
- Score of < 9 on the PHQ-4
- Patients must have a FSFI desire subscale baseline score less than 3.3
- NOTE-Both the PHQ4 and FSFI must be completed by the patient and data entered in Oncology Patient Enrollment Network (OPEN) at Step 1 registration to determine eligibility
- Diagnosis of breast or gynecologic cancer (examples are DCIS, LCIS, invasive breast, ovarian, endometrial, vulvar, cervical and vaginal)
- Completed definitive therapy consisting of surgery, chemotherapy or radiation therapy at least 180 days ago (may continue on Herceptin or endocrine therapy)
- Post menopausal as defined by at least ONE of the following:
- 12 months (365 days) without a period,
- Bilateral oophorectomy,
- For women 57 and under, if at least one ovary and woman has had hysterectomy, must have follicle stimulating hormone (FSH) (> 30 mIU/mL) and estradiol in menopausal range per institution?s laboratory (< 10 for ultra sensitive assay: < 25-30 otherwise);
- At least one ovary intact and 180 days without a period with FSH (> 30 mIU/mL) and estradiol in menopausal range per institution's laboratory (< 10 for ultra sensitive assay: < 25-30 otherwise); Note: Women 58 and older do not have to have hormonal tests.
- History, physical and performance status of 2 or less within 180 days prior to registration
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
- Total bilirubin =< 1.5 x ULN
- Glomerular filtration rate > 90ml/min
- For breast cancer patients only, endocrine therapies are allowed (such as aromatase inhibitors, but not current tamoxifen. Prior tamoxifen is permitted with a 30 day wash out period).
- Vaginal estrogen is allowed, for all protocol disease sites, if dose equal to or less than that in estring (< 7.5 mcg) and it has been used for at least 30 days with no plans to stop or alter use during the course of the study
- Antidepressants for mood and hot flashes, including SSRI's will be allowed if patients have been on a stable dose for the last 60 days and the dose is not expected to change during the course of the study; only subthreshold or low dose antidepressants will be allowed (e.g. Effexor up to 75 mg or Lexapro 5-10 mg or Celexa 10- 20 mg)
- The patient must provide study-specific informed consent prior to study entry/screening
- Women who report that their motivation/desire for sexual intimacy has decreased since her cancer diagnosis
- Able to swallow whole capsules
- Proficient in English (due to number of questionnaires not validated in other languages)
- Completion of the FSFI and PHQ4; both questionnaires will be required and data entered at the time of step 1 registration
Prior to Step 2 Randomization
- Completion of the following baseline quality of life forms: PHQ4, FSFI, PROMIS sexual function and satisfaction, PROMIS fatigue short form 8a, Impact of Treatment Scale, patient reported outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) items, and revised dyadic adjustment scale; these quality of life forms will be required and data must be entered in RAVE at step 2 registration; if available at the time of step 1 registration, step 2 registration can take place immediately after step 1; women who do not currently have a partner do not have to complete the revised dyadic adjustment scale; enter "no partner" for this form
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Untreated depression, major depressive disorder (MDD), suicidal ideations or anxiety disorders in the past 5 years per the medical chart based on Diagnostic and Statistical Manual (DSM) IV diagnoses
- Seizure disorders
- Current or history of anorexia or bulimia in the past 5 years
- Allergy to bupropion
- Use of drugs metabolized by CYP2D6
- Stage IV cancer
- History of Parkinson's disease, multiple sclerosis or fibromyalgia
- Extensive pelvic exenteration surgery, surgeries which include partial or total vaginectomy with or without reconstruction; radical vulvectomy with or without remove of clitoris
- Women who are currently undergoing or planning to undergo reconstruction surgery during the course of the study; women who have completed reconstruction surgery must be 30 days from surgery
- Oral or transdermal estrogen therapy is not allowed
- Males are not permitted to participate
- Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs after chronic use
- Patients who discontinue monoamine oxidase (MAO)-inhibitor (I)'s within 14 days prior to starting the investigational drug
- Poorly controlled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 100 mmHg) on three or more readings in the past 12 months
- Patients with active bipolar disorder
- Patients with impaired decision making as determined by the treating physician
- Concurrent use of bupropion
- Concomitant invasive malignancy requiring treatment other than non-melanomatous skin cancer.
- Previous or concurrent use of flibanserin.
To learn more, visit ClinicalTrials.Gov
Amanda Hathaway, MD