Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer
Condition: Breast Carcinoma; Cervical Carcinoma; Ovarian Carcinoma; Postmenopausal; Uterine Corpus Cancer; Vaginal Carcinoma; Vulvar Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms
Intervention: Bupropion 150 mg XL; Placebo
Intervention description: By mouth; By mouth
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 230.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 PHQ-4 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 lobular carcinoma in situ
             (LCIS),ductal carcinoma in situ (DCIS), 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;

               -  Chemically induced menopause as long as there are no plans to stop during the
                  study;

               -  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 selective serotonin reuptake
             inhibitors (SSRIs) 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 PHQ-4; 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: PHQ-4, 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 Medidata 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

        Exclusion Criteria:

          -  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.