Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Hot Flashes

All Drugs and Chemicals

Psychotropic Drugs

Urological Agents

Aromatase Inhibitors

Paroxetine

Oxybutynin

Selective Serotonin Reuptake Inhibitors

Serotonin

Neurotransmitter Agents

Antidepressive Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Parasympatholytics

Muscarinic Antagonists

Cholinergic Antagonists

Cholinergic Agents

One study group will receive 10 mg of oxybutynin ER orally once daily for 12 weeks

the other group will receive 12.5 mg of paroxetine CR orally once daily for 12 weeks

One study group will receive 10 mg of oxybutynin ER orally once daily for 12 weeks.

oxybutynin ER

the other group will receive 12.5 mg of paroxetine CR orally once daily for 12 weeks.

Paroxetine CR

Alaa El-Sayed

alaa el sayed

Breast cancer is the most prevalent cancer type worldwide. In Egypt, It is the second most common type of cancer and the most common one in women with about 22 thousand new cases in 2020. Around 70% of newly diagnosed patients are hormone receptor-positive and, unfortunately, the disease is often diagnosed at the advanced stage.

In postmenopausal women with hormone receptor-positive breast cancer, aromatase inhibitors (AIs) are the first-line adjuvant therapy according to National Comprehensive Cancer Network (NCCN) guidelines. Although, they showed superiority in efficacy to tamoxifen in this type of breast cancer, one of the most annoying adverse effects of the aromatase inhibitors are the vasomotor symptoms. They could be as severe as the patient would prefer discontinuing the medication. The underlying mechanism responsible for those adverse effects is that AIs suppress plasma estrogen levels by inhibiting the enzyme responsible for the conversion of androgens to estrogens in peripheral tissues. This estrogen depletion has been linked to an increase in hot flushes by decreasing endorphin levels and increasing that of norepinephrine and serotonin, followed by instability of the hypothalamic thermoregulatory set point which allows changes in the body temperature and in hot flash sensation.

Hormone replacement therapy is considered first-line treatment for vasomotor symptoms. However, it is not preferred to be used in breast cancer patients especially those with hormone receptor positive breast cancer. So, many drugs have been investigated for their efficacy in reducing the frequency and severity of vasomotor symptoms. The only FDA-approved drug to treat moderate-to-severe vasomotor symptoms is paroxetine. Paroxetine is a selective serotonin reuptake inhibitor (SSRI) which is used mainly in major depressive disorder and other psychiatric conditions like anxiety disorders. It has proved an efficacy in reducing frequency and severity of hot flushes in post-menopausal women. But, there are several concerns regarding its use with tamoxifen in breast cancer patients. There is a competition between paroxetine and tamoxifen for hepatic CYP2D6, so, paroxetine prevents conversion of tamoxifen into its active metabolite.

Oxybutynin has shown efficacy in relieving vasomotor symptoms. Oxybutynin is an anticholinergic used usually in urinary incontinence. It has an advantage over other SSRIs that it lacks the interaction with tamoxifen on CYP2D6 and, therefore, with the anticancer effect of tamoxifen treatment in breast cancer patients.

To our knowledge, there are no head-to-head studies comparing the efficacy and safety of paroxetine versus oxybutynin in reducing frequency and severity of vasomotor symptoms especially in breast cancer patients taking aromatase inhibitors.

Efficacy and Safety of Oxybutynin Versus Paroxetine in Aromatase Inhibitor-induced Vasomotor Symptoms

Efficacy and Safety of Oxybutynin Versus Paroxetine in Breast Cancer Patients With Aromatase Inhibitor-induced Vasomotor Symptoms.

Comparing the efficacy of oxybutynin to paroxetine in reducing frequency and severity of moderate to severe vasomotor symptoms in breast cancer patients receiving aromatase inhibitors using hot flashes diary.

Comparing the efficacy of oxybutynin to paroxetine in reducing sleep disturbances in breast cancer patients receiving aromatase inhibitors using The Pittsburgh Sleep Quality Index questionnaire.

Comparing the safety of oxybutynin to paroxetine through an every-other-week assessment of possible adverse events (dry mouth, dyspepsia, diarrhea, constipation, urinary tract infections, suicidal ideation, fatigue, headache, dizziness, etc.).

Comparing the safety of oxybutynin to paroxetine on kidney through assessment of serum creatinine abnormalities on week 12 compared to baseline.

Comparing the safety of oxybutynin to paroxetine on kidney through assessment of blood urea nitrogen abnormalities on week 12 compared to baseline.

Comparing the safety of oxybutynin to paroxetine through assessment of Alanine aminotransferase abnormalities on week 12 compared to baseline.

Comparing the safety of oxybutynin to paroxetine through assessment of aspartate aminotransferase abnormalities on week 12 compared to baseline.

Comparing the safety of oxybutynin to paroxetine through assessment of bilirubin abnormalities on week 12 compared to baseline.

Cairo University

Teaching assistant, principal investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Flushing

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Reproductive Control Agents

Cyproterone Acetate

Cyproterone

Androgens

Androgen Antagonists

Hormones

Hormone Antagonists

Contraceptive Agents

Contraceptive Agents, Male

Cyproterone acetate 5

Placebo

Cyproterone acetate 15

Cyproterone acetate 25

Duramed Protocol Chair

This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer patients with hot flashes following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period.

This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer in patients with mild to moderate vasomotor symptoms (hot flashes) following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. To be eligible for this study prostate cancer patients must have undergone bilateral orchiectomy or medical castration utilizing LHRH analogues (LHRH agonists or LHRH antagonists) with or without additional antiandrogen therapy. Patients must have at least 21 moderate to severe hot flashes weekly.

Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period. In addition, a brief physical evaluation will be done, diaries will be reviewed and any adverse events will be recorded at each follow-up evaluation.

A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients

A Dose-ranging Clinical Trial to Study the Efficacy and Safety of DR-2031 for the Treatment of Hot Flashes Following Surgical or Medical Castration of Prostate Cancer Patients

Duramed Research

Ganglion Cysts

Synovial Cyst

Central Nervous System Depressants

Bupivacaine

Anesthetics

Anesthetics, Local

Stellate Ganglion Block Injection with bupivicaine

A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.

Stellate Ganglion Block injection with bupivicaine

Saline

David R. Walega, MD, MSCI

Vasomotor symptoms (hot flashes, night sweats, VMS) affect up to 65% of breast cancer survivors and negatively impact their quality of life. VMS in Hispanic women are significantly more severe as compared to non-Hispanic Caucasian women. Few effective treatments for VMS are available, especially in the underserved Hispanic and Spanish-speaking populations which is problematic, as Hispanics will comprise 20% of the U.S. population by 2025. Stellate ganglion nerve block (SGB) with local anesthetic, previously performed for chronic pain indications, has shown promise as a potential treatment for menopausal women with VMS in previous clinical trials, but has not been investigated in Hispanic or Spanish-Speaking women with breast cancer in a controlled study.

In this study, investigators aim to assess the effects of SGB on VMS, sympathetic nervous system activity, depression and sleep in Hispanic and Spanish-Speaking women with breast cancer on endocrine therapy who take tamoxifen, aromatase inhibitors (AIs) or SERMS, in a prospective, randomized, sham-controlled pilot study.

Project Hypothesis: The frequency and intensity of subjective and objective VMS will be significantly lower in women randomized to active SGB as compared to sham control.

Project Scope: Hispanic and Spanish-speaking women with breast cancer on tamoxifen, aromatase inhibitors or SERMs with moderate to severe VMS will be enrolled as participants in this study. Eligible women will be specifically recruited from the oncology practice of Dr. Cesar Santa Maria, as well as Northwestern Memorial Hospital and other Northwestern affiliates.

Specific Goals and Objectives:

Goal 1: Determine the effect of stellate ganglion blockade (SGB) for reducing subjective and objective VMS in Hispanic women with breast cancer on endocrine therapy as this population is known to have a greater severity of VMS and has been notoriously underserved and understudied in the U.S. and in clinical trials.

Goal 2: Evaluate the effect of SGB on the sympathetic nervous system over time to gain new knowledge on the physiologic mechanism of SGB effects on VMS.

Goal 3: Evaluate the effect of SGB on mood, sleep, and quality of life in women with breast cancer on tamoxifen, AIs, or SERMs.

Goal 4: Using the results of this pilot study, investigators plan to submit an R01 grant to the National Cancer Institute in 2017 for a larger scale study.

Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer

Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer: A Pilot Randomized Sham-Controlled Trial

2 month subject reported daily hot flashes measured from day 60 to day 90 after treatment (mean value).

Indiana University

University of Illinois at Chicago

Northwestern University

Associate Professor of Anesthesiology

Stellate Ganglion Block Injection with bupivicaine

Stellate Ganglion Block injection with bupivicaine: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.

Bupivicaine

Saline injection

Saline: sham injection with saline

Total

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Mean number of hot flashes per night for one month before treatment as reported by the study participant.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Oxybutynin Versus Paroxetine in Aromatase Inhibitor-induced Vasomotor Symptoms	NCT05637671	Vasomotor Sympt...	oxybutynin ER Paroxetine CR	-	Cairo University
A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients	NCT00196339	Prostate Cancer	Cyproterone ace... Placebo Cyproterone ace... Cyproterone ace...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients	NCT00196339	Prostate Cancer	Cyproterone ace... Placebo Cyproterone ace... Cyproterone ace...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer	NCT03122301	Hot Flashes Hot Flushes Vasomotor Sympt...	Stellate Gangli... Saline	30 Years - 70 Years	Northwestern University

Spots Global Cancer Trial Database for vasomotor symptoms