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Bupropion Hydrochloride in Im...

Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer

Last Updated: 2022-03-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2021-02-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Carcinoma Cervical Carcinoma Ovarian Carcinoma Postmenopausal Uterine Corpus Cancer Vaginal Carcinoma Vulvar Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

Bupropion 150 mg XL

Intervention Type DRUG

By mouth

Placebo

Intervention Type DRUG

By mouth

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)

Group Type EXPERIMENTAL

Bupropion 150 mg XL

Intervention Type DRUG

By mouth

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)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

By mouth

Interventions

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Bupropion 150 mg XL

By mouth

Intervention Type DRUG

Placebo

By mouth

Intervention Type DRUG

Other Intervention Names

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Amfebutamone BUPROPION HYDROCHLORIDE BW 323U66 Forfivo XL Wellbutrin Zyban

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Debra Barton

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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Kaiser Permanente-Anaheim

Anaheim, California, United States

Site Status

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Site Status

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Site Status

Kaiser Permanente-Bellflower

Bellflower, California, United States

Site Status

Kaiser Permanente Dublin

Dublin, California, United States

Site Status

Kaiser Permanente-Fontana

Fontana, California, United States

Site Status

Kaiser Permanente-Fremont

Fremont, California, United States

Site Status

Kaiser Permanente-Fresno

Fresno, California, United States

Site Status

Kaiser Permanente - Harbor City

Harbor City, California, United States

Site Status

Kaiser Permanente-Irvine

Irvine, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Kaiser Permanente-Cadillac

Los Angeles, California, United States

Site Status

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Kaiser Permanente-Modesto

Modesto, California, United States

Site Status

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status

Kaiser Permanente-Ontario

Ontario, California, United States

Site Status

Kaiser Permanente - Panorama City

Panorama City, California, United States

Site Status

Kaiser Permanente-Redwood City

Redwood City, California, United States

Site Status

Kaiser Permanente-Richmond

Richmond, California, United States

Site Status

Kaiser Permanente-Riverside

Riverside, California, United States

Site Status

Kaiser Permanente-Roseville

Roseville, California, United States

Site Status

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Site Status

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente - Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente-San Diego Zion

San Diego, California, United States

Site Status

Kaiser Permanente-San Francisco

San Francisco, California, United States

Site Status

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Site Status

Kaiser Permanente San Leandro

San Leandro, California, United States

Site Status

Kaiser Permanente-San Marcos

San Marcos, California, United States

Site Status

Kaiser Permanente-San Rafael

San Rafael, California, United States

Site Status

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Site Status

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Site Status

Kaiser Permanente-Stockton

Stockton, California, United States

Site Status

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Site Status

Kaiser Permanente-Vallejo

Vallejo, California, United States

Site Status

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Site Status

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

Site Status

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Denver Health Medical Center

Denver, Colorado, United States

Site Status

Kaiser Permanente-Franklin

Denver, Colorado, United States

Site Status

National Jewish Health-Main Campus

Denver, Colorado, United States

Site Status

The Women's Imaging Center

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Site Status

SCL Health Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Site Status

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

National Jewish Health-Western Hematology Oncology

Golden, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Kaiser Permanente-Rock Creek

Lafayette, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Site Status

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

National Jewish Health-Northern Hematology Oncology

Thornton, Colorado, United States

Site Status

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status

TidalHealth Nanticoke / Allen Cancer Center

Seaford, Delaware, United States

Site Status

Florida Gynecologic Oncology

Fort Myers, Florida, United States

Site Status

Regional Cancer Center-Lee Memorial Health System

Fort Myers, Florida, United States

Site Status

Augusta University Medical Center

Augusta, Georgia, United States

Site Status