Bellflower, California 90706


Purpose:

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.


Study summary:

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). OUTLINE: Patients are randomized to 1 of 3 arms. ARM A: Patients receive bupropion hydrochloride orally (PO) once daily (QD) on days 1-63 and placebo PO QD on days 8-71. ARM B: Patients receive bupropion hydrochloride PO QD on days 1-7 and 64-71, and twice daily (BID) on days 8-63. ARM C: Patients receive placebo PO QD on days 1-7 and 64-71, and BID on days 8-63.


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 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 woment 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 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.


Study is Available At:


Original ID:

NRG-CC004


NCT ID:

NCT03180294


Secondary ID:

NCI-2017-00344


Study Acronym:


Brief Title:

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


Official Title:

Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women With Breast or Gynecologic Cancer


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NRG Oncology


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

234


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Debra Barton
Principal Investigator
NRG Oncology

Study Dates

Start Date:May 31, 2017
Completion Date:May 31, 2027
Completion Type:Anticipated
Primary Completion Date:October 30, 2019
Primary Completion Type:Anticipated
Verification Date:September 2019
Last Changed Date:September 3, 2019
First Received Date:June 6, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in sexual desire, as measured by the desire subscale of the female sexual function index
Time Frame:Baseline up to 9 weeks
Safety Issues:False
Description:Will be tested between both bupropion arms and the control arm using a t-test with each comparison having a 1-sided significance level of 0.05. Effect sizes between placebo and each treatment arm will be reported. The desire subscale will be scored at eac
Outcome Type:Secondary Outcome
Measure:Depressive mood as measured by the patient health questionnaire-4
Time Frame:Up to 9 weeks
Safety Issues:False
Description:Depressive mood at each time point will be compared between the placebo and each intervention arm using a t-test, or Wilcoxon test if the data is non-normal, and compared at the one-sided 0.05 significance level.
Outcome Type:Secondary Outcome
Measure:Fatigue as measured by Patient Reported Outcomes Measurement Information System fatigue scale
Time Frame:Up to 9 weeks
Safety Issues:False
Description:Will be compared between the placebo and each intervention arm using a t-test, or Wilcoxon test if the data is non-normal, and compared at the one-sided 0.05 significance level. Spearman correlation coefficients will be used to assess the association betw
Outcome Type:Secondary Outcome
Measure:Incidence of adverse events including patient reported outcomes-Common Terminology Criteria for Adverse Events assessed using Common Terminology Criteria for Adverse Events 4.0
Time Frame:Up to 9 weeks
Safety Issues:False
Description:Adverse events will also be assessed using patient reported outcomes-Common Terminology Criteria for Adverse Events items. Patient reported outcomes-Common Terminology Criteria for Adverse Events items of Interest that are associated with potential drug s
Outcome Type:Secondary Outcome
Measure:Sexual desire as measured by the desire subscale of the female sexual function index
Time Frame:Baseline up to 9 weeks
Safety Issues:False
Description:Will include comparison of the placebo and intervention arms of the change from baseline to 5 weeks for both sexual desire tools as well as the change from baseline to 9 weeks using the Patient Reported Outcomes Measurement Information System sexual desir
Outcome Type:Secondary Outcome
Measure:Sexual functioning as measured by the female sexual function index total score
Time Frame:Baseline up to 9 weeks
Safety Issues:False
Description:Will be compared between the placebo and each intervention arm using a t-test, or Wilcoxon test if the data is non-normal, and compared at the one-sided 0.05 significance level. Longitudinal trends in female sexual function index total score will be asses

Study Interventions

Intervention Type:Drug
Name:Bupropion Hydrochloride
Description:Given PO
Arm Name:Arm A (bupropion hydrochloride, placebo)
Other Name:Amfebutamone
Intervention Type:Other
Name:Placebo
Description:Given PO
Arm Name:Arm A (bupropion hydrochloride, placebo)
Other Name:placebo therapy

Study Arms

Study Arm Type:Experimental
Arm Name:Arm A (bupropion hydrochloride, placebo)
Description:Patients receive bupropion hydrochloride PO QD on days 1-63 and placebo PO QD on days 8-71.
Study Arm Type:Experimental
Arm Name:Arm B (bupropion hydrochloride)
Description:Patients receive bupropion hydrochloride PO QD on days 1-7 and 64-71, and BID on days 8-63.
Study Arm Type:Placebo Comparator
Arm Name:Arm C (placebo)
Description:Patients receive placebo PO QD on days 1-7 and 64-71, and BID on days 8-63.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:NRG Oncology
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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