Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women With Breast or Gynecologic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- NRG Oncology
- 入组人数
- 230
- 试验地点
- 706
- 主要终点
- Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index ("Sexual Desire")
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Bupropion 150 mg
One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule daily for 8 weeks; one placebo capsule daily for one 1 week (titration off).
干预措施: Placebo (Drug)
Placebo
One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
干预措施: Placebo (Drug)
Bupropion 150 mg
One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule daily for 8 weeks; one placebo capsule daily for one 1 week (titration off).
干预措施: Bupropion 150 mg XL (Drug)
Bupropion 300 mg
One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
干预措施: Bupropion 150 mg XL (Drug)
结局指标
主要结局
Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index ("Sexual Desire")
时间窗: Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization)
The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as "sexual desire" in the protocol.
次要结局
- Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score(Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization))
- Change From Baseline at 5 Weeks in Desire Subscore of the FSFI ("Sexual Desire")(Baseline (prior to randomization) and 5 weeks from start of study treatment (within 21 days of randomization))
- Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure ("Sexual Desire and Satisfaction")(Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization))
- Change From Baseline in FSFI Total Score ("Sexual Functioning")(Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization))
- Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score ("Depressive Mood")(Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization))
- Global Impression of Change at 9 Weeks ("Perception of Change")(9 weeks from start of study treatment (within 21 days of randomization))
- Perception of Risk vs. Benefit at 9 Weeks(9 weeks from start of study treatment (within 21 days of randomization))
- Number of Participants With a Grade 3 or Higher Adverse Event Over the Course of the Study(Adverse events were evaluated 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).)
- Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks(9 weeks from start of study treatment (within 21 days of randomization).)