Solifenacin vs Clonidine for Hot Flashes in Breast Cancer Patients

Overseen By Allen C Sherman, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Arkansas

Must be taking: Aromatase inhibitors, Tamoxifen

Must not be taking: Tricyclics, MAOIs, Barbiturates, others

Disqualifiers: Renal impairment, Chemotherapy, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

110 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking clonidine or solifenacin for at least one month before participating. If you are on non-tricyclic antidepressants or gabapentin, you must not change your regimen in the past 4 weeks. Other medications like tricyclic antidepressants, certain antidepressants, and specific enzyme inducers or inhibitors are not allowed.

What data supports the effectiveness of the drug clonidine for hot flashes in breast cancer patients?

Research shows that clonidine can significantly reduce the frequency of hot flashes in postmenopausal women, with a study indicating a 46% decrease in hot flash occurrence at the highest dosage. Additionally, clonidine has been found effective in reducing hot flashes in menopausal women, making it a potential option for those who cannot use estrogen-based therapies. ^{1 2 3 4 5}

How does the drug clonidine differ from other treatments for hot flashes in breast cancer patients?

Clonidine is unique because it is originally a medication for high blood pressure, but it has been found to significantly reduce the frequency of hot flashes in breast cancer patients, especially those experiencing menopause due to treatment. Unlike hormone-based therapies, clonidine offers a non-hormonal option, which is important for breast cancer patients who often need to avoid hormones. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Research Team

Allen C Sherman, PhD

Principal Investigator

Universitiy of Arkansas for Medical Sciences

Eligibility Criteria

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.

Inclusion Criteria

I am currently on aromatase inhibitors or tamoxifen.

I have had invasive breast cancer or DCIS before.

I have not been on hormone replacement therapy for at least a month.

Exclusion Criteria

I am not currently using clonidine or solifenacin, or I stopped using them over a month ago.

I am currently undergoing or planning to start chemotherapy or radiotherapy soon.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either solifenacin or clonidine for 3 weeks to evaluate the reduction of hot flashes

3 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Clonidine
• Solifenacin

Trial Overview 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.

Participant Groups

Group I: solifenacin Experimental Treatment 1 Intervention

oral solifenacin 5.0 mg daily for 3 weeks

Group II: clonidine Active Control 1 Intervention

oral clonidine 0.1 mg daily for 3 weeks

Clonidine is already approved in United States, European Union for the following indications:

Approved in United States as Catapres for:

• Hypertension
• ADHD
• Severe cancer pain
• Withdrawal symptoms from various substances
• Diagnosis of pheochromocytoma
• Prevention of migraines

Approved in European Union as Catapres for:

• Hypertension
• ADHD
• Severe cancer pain
• Withdrawal symptoms from various substances
• Diagnosis of pheochromocytoma
• Prevention of migraines

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

References

1. South Africa pubmed.ncbi.nlm.nih.gov

A comparison of oestrogen-progestogen with clonidine in the climacteric syndrome. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of clonidine on hot flashes in postmenopausal women. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Transdermal clonidine for ameliorating tamoxifen-induced hot flashes. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Venlafaxine versus clonidine for the treatment of hot flashes in breast cancer patients: a double-blind, randomized cross-over study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Studies with clonidine (dixarit) in menopausal women. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Management of hot flashes in patients who have breast cancer with venlafaxine and clonidine: a randomized, double-blind, placebo-controlled trial. [2022]