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Alpha-2 Adrenergic Agonist

Solifenacin vs Clonidine for Hot Flashes in Breast Cancer Patients

Phase 2

Waitlist Available

Led By Allen C Sherman, PhD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently taking aromatase inhibitors or tamoxifen

Women with a history of invasive breast cancer or DCIS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from consent until end of study (approximately 9 weeks)

Awards & highlights

Study Summary

This trial found that solifenacin was more effective than clonidine at reducing the number of hot flashes experienced by breast cancer patients.

Who is the study for?

This trial is for women over 18 with a history of invasive breast cancer or DCIS, experiencing hot flashes while on aromatase inhibitors or tamoxifen. They must not have used hormone replacement therapy recently and should not be undergoing chemotherapy or radiotherapy soon. Participants shouldn't have severe heart, liver, kidney issues, uncontrolled glaucoma, urinary retention, certain blood pressure conditions or be taking conflicting medications.Check my eligibility

What is being tested?

The study compares solifenacin (a drug that blocks certain nerve receptors) to clonidine (commonly used for hot flashes) in reducing hot flashes among breast cancer patients. It aims to determine which medication is more effective at alleviating this common symptom experienced during hormonal therapies.See study design

What are the potential side effects?

Solifenacin may cause dry mouth, constipation, blurred vision and difficulty urinating. Clonidine can lead to drowsiness, dry mouth, headache and potentially low blood pressure. The severity of side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently on aromatase inhibitors or tamoxifen.

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I have had invasive breast cancer or DCIS before.

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I am 18 years old or older.

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I have been experiencing hot flashes for at least a month.

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I experience hot flashes at least 14 times a week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from consent until end of study (approximately 9 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from consent until end of study (approximately 9 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from consent until end of study (approximately 9 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy: hot flash composite and frequency scores (daily diary)

Safety: number of clinician-rated adverse events

Secondary outcome measures

daily functioning (Hot Flash-Related Daily Interference score)

quality of life (Illness Cognition Questionnaire, SF-12)

sleep (Insomnia Severity Index)

Side effects data

From 2008 Phase 4 trial • 132 Patients • NCT00431041

35%

Dry Mouth

13%

Constipation

Fatigue

Urinary tract infection

Headache

Dizziness

Cough

Somnolence

fracture, right foot

Cervical adenocarcinoma in situ

Worsening depression

Dysphagia

100%

80%

60%

40%

20%

Study treatment Arm

Solifenacin

Oxybutynin IR

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: solifenacinExperimental Treatment1 Intervention

oral solifenacin 5.0 mg daily for 3 weeks

Group II: clonidineActive Control1 Intervention

oral clonidine 0.1 mg daily for 3 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

solifenacin

2006

Completed Phase 4

~9070

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor

486 Previous Clinical Trials

150,347 Total Patients Enrolled

Allen C Sherman, PhDPrincipal InvestigatorUniversitiy of Arkansas for Medical Sciences

Media Library

Clonidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT01530373 — Phase 2

Hot Flashes Research Study Groups: clonidine, solifenacin

Hot Flashes Clinical Trial 2023: Clonidine Highlights & Side Effects. Trial Name: NCT01530373 — Phase 2

Clonidine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01530373 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is this experiment's participant pool populated?

"Unfortunately, this clinical trial has already ceased its recruitment process. Initially posted on February 1st 2012 and last updated June 8th 2022, the study is now closed. If you're seeking other studies to join, there are currently 2617 trials that accept participants suffering from hot flashes and 24 trials for solifenacin recruiting at this time."

Answered by AI

Has the FDA approved solifenacin for public consumption?

"Despite this being a Phase 2 trial, with limited evidence for efficacy, solifenacin is assessed as having an intermediate safety rating of 2."

Answered by AI

What are the typical therapeutic applications of solifenacin?

"Solifenacin is a common therapy for diabetic diarrhea, with the drug also being successful in relieving symptoms of menopause, ADHD and pheochromocytomas."

Answered by AI

Is this clinical research still actively recruiting participants?

"The clinicaltrials.gov platform reveals that this medical trial is no longer accepting participants, with its most recent update dating back to June 8th 2022. Initially published on February 1st 2012, the current 2641 studies recruiting patients are not including this one."

Answered by AI

Are there any historical records which demonstrate the efficacy of solifenacin in clinical trials?

"Presently, 24 trials related to solifenacin are underway with 8 of these experiments in the final phase. Of those 80 clinical sites facilitating studies on solifenacin, multiple are located near Boston, Massachusetts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2012. "Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01530373.

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