Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients

Launched by UNIVERSITY OF ARKANSAS · Feb 7, 2012

Keywords

ClinConnect Summary

This clinical trial is studying two medications, solifenacin and clonidine, to see which one is more effective in reducing hot flashes in women who have had breast cancer. Hot flashes can be a major issue for these patients, especially those taking certain hormone therapies like aromatase inhibitors or tamoxifen. The trial is looking for women aged 18 and older who have a history of invasive breast cancer or ductal carcinoma in situ (DCIS) and are experiencing hot flashes at least 14 times a week for at least a month. Participants should not have received any other treatments for hot flashes in the past month.

If eligible, participants can expect to take one of the two medications and be monitored for their hot flash symptoms during the study. This trial is currently active but not recruiting new participants. It's important to note that certain health conditions or medications may exclude someone from participating, so potential volunteers should discuss their individual situation with their healthcare provider to see if they qualify. This study aims to help improve the quality of life for breast cancer survivors by finding effective treatments for hot flashes.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women with a history of invasive breast cancer or DCIS
• • Currently taking aromatase inhibitors or tamoxifen
• • Not receiving hormone replacement therapy for minimum of one month
• • Age 18 years or older
• • Self-reported hot flashes at least fourteen times per week
• • Self-reported hot flashes for at least one month
• • If receiving non-tricyclic antidepressants (venlafaxine, paroxetine, citalopram, sertraline, etc.) or gabapentin, no change in regimen in past 4 weeks.
• Exclusion Criteria:
• • Receiving any other treatment for hot flashes within the past month, including estrogens, progestins, androgens, or gabapentin.
• • Current use of clonidine or solifenacin. (If patients have been off of these for one month, then they are eligible)
• • History of severe renal or moderate or severe hepatic impairment, as indicated by physical exam and medical record
• • Concurrent or planned chemotherapy or radiotherapy (within next 3 months)
• • Currently receiving tricyclic antidepressants, monoamine oxidase inhibitors, barbiturates, pimozide.
• • Currently using CYP3A4 inducers (i.e., aminoglutethimide, carbamazepine, dexamethasone, efavirenz, ethosuximide, griseofulvin, modafinil, nafcillin, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's Wort, sulfadimidine, sulfinpyrazone, troglitazone) or potent CYP3A4 inhibitors (i.e., chloramphenicol, clarithromycin, erythromycin, imatinib mesylate, indinavir sulfate, itraconazole, ketoconazole, nefazoldone, nelfinavir mesylate, ritonavir, telithromycin, troleandomycin).
• • Uncontrolled or poorly controlled narrow-angle glaucoma, urinary retention, gastric retention (evaluated from history \& physical exam and medical record)
• • Hypotension or uncontrolled hypertension (160/95 \> BP \< 100/60)
• • Severe coronary insufficiency, conduction disturbances, recent myocardial infarction (within past 3 months), cerebrovascular disease, syncope (evaluated from history \& physical and medical record)
• • History of allergy or adverse reactions to clonidine or solifenacin
• • ECOG status \> 2 (in bed more than 50% of day)