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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how effectively two medications, solifenacin and clonidine, reduce hot flashes in breast cancer patients. Hot flashes can significantly affect those taking hormonal treatments like tamoxifen. Participants will take either solifenacin or clonidine (commonly used for high blood pressure) daily for three weeks to determine which is more effective. This trial suits women with breast cancer who experience frequent hot flashes, at least 14 times a week, and are currently on aromatase inhibitors or tamoxifen. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that solifenacin is usually well-tolerated. It calms symptoms of an overactive bladder and may also reduce hot flashes. However, high doses can cause side effects like dry mouth or constipation. Serious reactions are rare but can include confusion or drowsiness if taken in excess.

Clonidine, another option studied for hot flashes, can reduce their frequency and severity but tends to have more noticeable side effects. Some individuals may experience dry mouth, tiredness, or dizziness.

Both treatments have been used for other health issues, providing insight into their safety. Solifenacin is approved for bladder problems, and clonidine is used for blood pressure and hot flashes. Consider personal health conditions before joining a trial. Always consult a doctor to determine if these treatments are suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about solifenacin and clonidine for treating hot flashes in breast cancer patients due to their unique mechanisms. Unlike standard treatments like hormone replacement therapy, solifenacin works by blocking specific receptors in the nervous system, potentially reducing hot flashes without hormonal effects. Clonidine, on the other hand, is traditionally used for high blood pressure but may help manage hot flashes by affecting the body's temperature regulation. These treatments offer new avenues for relief, especially for patients who can't use hormone-based therapies.

What evidence suggests that this trial's treatments could be effective for hot flashes in breast cancer patients?

This trial will compare the effectiveness of solifenacin and clonidine in reducing hot flashes in breast cancer patients. Research has shown that clonidine, which participants in this trial may receive, can help reduce hot flashes. Studies have found that clonidine can lower the number of hot flashes by about 20% and make them 10% less severe. Another study found that people taking clonidine experienced a 37% reduction in hot flashes, compared to a 20% reduction in those not taking it.

Solifenacin, another treatment option in this trial, is also being tested as a possible treatment for hot flashes. Known for calming overactive muscles, solifenacin is being studied for its potential to help women experiencing hot flashes during breast cancer treatment. While detailed results on solifenacin's effectiveness for hot flashes are still being collected, its mechanism suggests it could be helpful. ^{2 3 6 7 8}

Who Is on the Research Team?

Allen C Sherman, PhD

Principal Investigator

Universitiy of Arkansas for Medical Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21911720/

Management of hot flashes in patients who have breast ... Conclusion: Venlafaxine and clonidine are effective treatments in the management of hot flashes in patients with breast cancer.

2. sciencedirect.com sciencedirect.com/science/article/pii/S092375341937869X

Venlafaxine is superior to clonidine as treatment of hot ... Conclusion: Venlafaxine is significantly more effective in reducing the frequency of hot flashes in breast cancer patients than clonidine. Previous article ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2826783/

Management of hot flashes in women with breast cancer - PMC Transdermal clonidine was found to reduce the frequency of hot flashes by 20% and the severity by a modest 10%. In another trial, Pandya et al. randomized 194 ...

4. acpjournals.org acpjournals.org/doi/10.7326/ACPJC-2001-134-1-024

Clonidine was effective for reducing tamoxifen-associated ... Main results. The clonidine group reported a greater reduction in the frequency of hot flashes at 4 weeks (mean percentage reduction 37% vs 20%, ...

5. aafp.org aafp.org/pubs/afp/issues/2006/0201/p457.html

Nonhormonal Therapies for Hot Flashes in Menopause Clonidine (Catapres) has been found to reduce hot flashes by 15 to 20 percent (ARR) compared with placebo (NNT = 5 to 7) in women with a history ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2971731/

Management of menopause-associated vasomotor symptoms Despite some positive results in these trials, the use of clonidine for hot flash treatment is not recommended because of significant side effects. Methyldopa.

7. ccjm.org ccjm.org/content/91/4/237

Nonhormone therapies for vasomotor symptom management Clonidine. Multiple studies demonstrate modest improvement in hot flashes with clonidine. One randomized, double-blind, placebo-controlled ...

8. thebms.org.uk thebms.org.uk/wp-content/uploads/2024/09/04-BMS-ConsensusStatement-Non-hormonal-based-treatments-SEPT2024-A.pdf

Non-hormonal-based treatments for menopausal symptoms Pharmacological and non- hormonal treatment of hot flashes in breast cancer survivors: CEPO review and recommendations. Support Care Cancer. 2013;21(5):1461 ...