Clinical trial · Interventional
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy
NCT01530373CI-TRIAL-00104658recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hot Flashes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clonidine | Drug | — | UNRESOLVED |
| solifenacin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- solifenacin
- description
- oral solifenacin 5.0 mg daily for 3 weeks
- interventionNames
- Drug: solifenacin
- type
- ACTIVE_COMPARATOR
- label
- clonidine
- description
- oral clonidine 0.1 mg daily for 3 weeks
- interventionNames
- Drug: Clonidine
Primary outcomes (2)
- measure
- Efficacy: hot flash composite and frequency scores (daily diary)
- timeFrame
- from baseline to end of treatment (3 weeks)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.