NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

NRG-CC004 - "PHASE II DOUBLE BLIND DOSE FINDING TRIAL OF BUPROPION VERSUS PLACEBO FOR SEXUAL DESIRE IN WOMEN WITH BREAST OR GYNECOLOGIC CANCER"

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please contact NCORP-KC for complete protocol information.



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Cancer Control Clinical Trial

CANCER TYPE: GYN
RESEARCH BASE: NRG
NCT NUMBER: NCT03180294
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM
UPDATED ON 10/02/2018 (16:57:52)

BRIEF DESCRIPTION

CC, breast or GYN ca, post definitive therapy, post menopausal, effects of bupropion on sexual desire. DCP-001 Eligible

NOTES


Treatment       (Supplied drug:  Bupropion/Placebo)

Arm A:

Bupropion XL 150mg, PO, 1 capsule daily for 1 week  THEN

Bupropion XL 150mg, PO, 1 capsule daily, and placebo 1 tablet daily for 8 weeks   THEN

Placebo, PO, 1 capsule daily for 1 week

Arm B:

Bupropion XL 150mg, PO, 1 capsule daily for 1 week  THEN

Bupropion XL 150mg, PO, 2 capsules daily for 8 weeks   THEN

Bupropion XL 150mg, PO, 1 capsule daily for 1 week

Arm C:

Placebo, PO, 1 capsule daily for 1 week  THEN

Placebo, PO, 2 capsules daily for 8 weeks   THEN

Placebo, PO, 1 capsule daily for 1 week  THEN

Optional open label bupropion at 150 mg XL once per day, may increase to 300 mg XL (two 150 mg XL at same time) if desired week 2
preference/response



ELIGIBILITY

Eligibility Step 1 Registration

  • Score of <9 on the PHQ-4 (screening questionnaire evaluating depression and anxiety)
  • Patients must have a FSFI (The Female Sexual Function Index questionnaire) desire subscale baseline score less than 3.3
    NOTE-Both the PHQ4 and FSFI must be completed by the patient and data entered in OPEN at Step 1 registration to determine eligibility.
  • Diagnosis of breast or gynecologic cancer (DCIS, 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,
    • At least one ovary and woman has had hysterectomy, must have FSH (>30mIU/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 (>30mIU/mL) and estradiol in menopausal range per institution’s laboratory (<10 for ultra sensitive assay: <25-30 otherwise);
  • Age ≥ 18;
  • History, Physical and Performance Status of 2 or less within 180 days prior to registration;
  • Adequate renal and hepatic function
    • AST and ALT < 2.5x ULN
    • Total bilirubin <1.5x ULN
    • Glomerular filtration rate >60ml/min. OR ≤ ULN creatinine per institution normals
  • For breast cancer patients only, endocrine therapies are allowed (such as aromatase inhibitors, but tamoxifen is not allowed).
  • 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 (i.e. Effexor 37.5 -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 questionnaries will be required and data entered at the time of step 1 registration.
  • No untreated depression, Major Depressive Disorder (MDD), suicidal ideations or anxiety disorders in the past 5 years per the medical chart based on DSM IV diagnoses.
  • No Seizure disorders
  • No Current or history of anorexia or bulimia in the past 5 years
  • No Allergy to bupropion
  • No Use of drugs metabolized by CYP2D6 (see Appendix I for a list of drugs and resources to look up durgs)
  • No Stage IV cancer
  • No History of Parkinson’s Disease, multiple sclerosis or fibromyalgia
  • No Extensive pelvic exenteration surgery, surgeries which include partial or total vaginectomy with or without reconstruction; radical vulvectomy with or without remove of clitoris
  • No 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
  • No Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbituates, and antiepileptic drugs after chronic use
  • No Patients who discontinue MAO-I’s within 14 days prior to starting the investigational drug
  • No Poorly controlled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg) on three or more readings in the past 12 months.
  • No Patients with active bipolar disorder
  • No Patients with impaired decision making as determined by the treating physician
  • No Concurrent use of bupropion
  • No Concomitant invasive malignancy requiring treatment other than non-melanomatous skin cancer.

Eligibility 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, PRO-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.





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