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Recruiting NCT01530373

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

Phase II Interventional Hot Flashes Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: solifenacin, Clonidine.
Who it may be relevant to
Registry conditions: Hot Flashes, Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy

Overview

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).

Detailed description

There has been considerable interest in developing new treatment strategies for managing hot flashes among women with breast cancer, in view of the limitations associated with currently available treatments. This randomized study evaluates the safety and efficacy of 3 weeks of solifenacin compared to 3 weeks of clonidine, for women receiving adjuvant hormonal therapy (aromatase inhibitors or tamoxifen) for breast cancer.

Interventions

  • Drug solifenacin
    oral solifenacin 5.0 mg daily for 3 weeks
  • Drug Clonidine
    oral clonidine 0.1 mg daily for 3 weeks

Primary outcome measures

  • Efficacy: hot flash composite and frequency scores (daily diary) [Time frame: from baseline to end of treatment (3 weeks)]
  • Safety: number of clinician-rated adverse events [Time frame: from consent until end of study (approximately 9 weeks)]
Secondary outcome measures (3)
  • daily functioning (Hot Flash-Related Daily Interference score) [Time frame: from baseline to end of treatment (3 weeks)]
  • sleep (Insomnia Severity Index) [Time frame: from baseline to end of treatment (3 weeks)]
  • quality of life (Illness Cognition Questionnaire, SF-12) [Time frame: from baseline to end of treatment (3 weeks)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences — Little Rock

Identifiers

NCT: NCT01530373 · 132500

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗