← Back to Search

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
Must not have
Currently receiving tricyclic antidepressants, monoamine oxidase inhibitors, barbiturates, pimozide
ECOG status > 2 (in bed more than 50% of day)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from consent until end of study (approximately 9 weeks)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests solifenacin and clonidine to help women with breast cancer who suffer from hot flashes due to their treatment. Solifenacin calms overactive muscles, while clonidine helps control body temperature.

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.
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.
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
Select...
I am currently on aromatase inhibitors or tamoxifen.
Select...
I have had invasive breast cancer or DCIS before.
Select...
I am 18 years old or older.
Select...
I have been experiencing hot flashes for at least a month.
Select...
I experience hot flashes at least 14 times a week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently taking certain medications for depression or other conditions.
Select...
I spend most of my day in bed due to my condition.
Select...
I do not have uncontrolled glaucoma, urinary, or gastric retention.
Select...
I have not had a recent heart attack or severe heart issues in the last 3 months.
Select...
I am currently taking medication that strongly affects liver enzymes.
Select...
I have a history of severe kidney or liver problems.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy: hot flash composite and frequency scores (daily diary)
Safety: number of clinician-rated adverse events
Secondary study objectives
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
6%
Fatigue
4%
Urinary tract infection
3%
Headache
3%
Dizziness
1%
Cough
1%
Somnolence
1%
fracture, right foot
1%
Cervical adenocarcinoma in situ
1%
Worsening depression
1%
Dysphagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Solifenacin
Oxybutynin IR

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Hot flashes are often treated with medications that target the autonomic nervous system to reduce symptoms. Solifenacin, a muscarinic acetylcholine receptor antagonist, works by blocking the M3 receptors, which helps to reduce the frequency and severity of hot flashes by inhibiting cholinergic stimulation that can trigger sweating and vasodilation. Clonidine, another common treatment, acts on alpha-2 adrenergic receptors to decrease sympathetic outflow, thereby reducing the occurrence of hot flashes. Understanding these mechanisms is crucial for patients as it helps them to comprehend how these medications can alleviate their symptoms and allows for informed discussions with their healthcare providers about the most suitable treatment options.
Influence of various cholinergic and anticholinergic drugs on rectal temperature in rats.Muscarinic M1 receptor agonist actions of muscarinic receptor agonists in rabbit vas deferens.Risk of delirium associated with antimuscarinics in older adults: A case-time-control study.

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
494 Previous Clinical Trials
150,568 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
~1 spots leftby Jul 2026