What side effects are associated with this type of intervention?

Common treatments for hot flashes, such as muscarinic acetylcholine receptor antagonists like solifenacin, often have side effects including dry mouth, constipation, and blurred vision. Other treatments for hot flashes, such as hormone therapy, can have side effects like nausea, breast tenderness, and an increased risk of blood clots. Non-hormonal treatments like SSRIs and SNRIs may cause side effects such as dizziness, headache, and gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved various treatments for hot flashes, particularly focusing on hormone therapies such as estradiol gels and sprays (e.g., EstroGel, Evamist). Alpha-adrenergic agonists like lofexidine and guanfacine have also been studied for their effectiveness in controlling vasomotor flushes, although larger doses may be required for significant therapeutic effects. Solifenacin, a muscarinic acetylcholine receptor antagonist, is currently being studied for its potential to reduce hot flashes, similar to its use in treating overactive bladder symptoms.

What other types of research exist?

Promising alternatives to Solifenacin for treating hot flashes in 2024 include Clonidine, which is already used for this purpose, and cognitive behavioral therapy (CBT), which has shown effectiveness in reducing menopausal symptoms. Additionally, ongoing research into new treatments, such as selective serotonin reuptake inhibitors (SSRIs) and other non-hormonal therapies, may provide novel options.

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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

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking certain medications for depression or other conditions.

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I spend most of my day in bed due to my condition.

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I do not have uncontrolled glaucoma, urinary, or gastric retention.

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I have not had a recent heart attack or severe heart issues in the last 3 months.

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I am currently taking medication that strongly affects liver enzymes.

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I have a history of severe kidney or liver problems.

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

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

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

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

0 / 11Eligibility criteria met

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.