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Compares treatment options for Hot Flashes
Official title Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
ClinicalTrials.gov ID: NCT01530373
What this study is testing
What is solifenacin?
solifenacin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hot flashes.
Also referred to as Vesicare.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Hot flashes present a considerable problem for many breast cancer patients; these symptoms may be intensified by hormonal therapies, such as aromatase inhibitors or tamoxifen. This study examines the value of solifenacin (a muscarinic acetylcholine receptor antagonist) in reducing hot flashes, compared with clonidine (a medication often used for treating hot flashes).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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.
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.