Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women With Breast or Gynecologic Cancer
Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women With Breast or Gynecologic 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.
PRIMARY OBJECTIVES:
I. Measure the ability of two dose levels of bupropion hydrochloride (bupropion), 150 or 300 mg of extended release, to improve sexual desire more than a placebo at 9 weeks (8 weeks on the target dose) as measured by the desire subscale of the female sexual function index (FSFI).
SECONDARY OBJECTIVES:
I. Evaluate the side effects of 150 and 300 mg bupropion extended release and differentiate these side effects from those observed in the placebo arm.
II. Evaluate the effect of 150 and 300 mg of bupropion extended release on the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale, PROMIS sexual desire and satisfaction measure, patient health questionnaire (PHQ)-4, and the FSFI total score, at 5 and 9 weeks, as well as the desire subscale score of the FSFI at 5 weeks.
III. Evaluate the effect of 150 and 300 mg of bupropion extended release on the global impression of change scale and the patient's perception of risk versus (vs.) benefit at 5 weeks (4 weeks at target dose) and 9 weeks (8 weeks at target dose).
Patients are randomized to 1 of 3 arms.
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
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:
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:
Brighton, Michigan 48114, United States
Chelsea, Michigan 48118, United States
East China Township, Michigan 48054, United States
Grand Rapids, Michigan 49503, United States
Saint Joseph, Michigan 49085, United States
Saint Joseph, Michigan 49085, United States
Ypsilanti, Michigan 48197, United States
American Fork, Utah 84003, United States
Silverdale, Washington 98383, United States
Stevens Point, Wisconsin 54482, United States
Sturgeon Bay, Wisconsin 54235-1495, United States
Summit, Wisconsin 53066, United States