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

Rare Diseases

Breast Diseases

Skin Diseases

Oculocerebral Syndrome With Hypopigmentation

Vasoconstrictor Agents

Venlafaxine Hydrochloride

Norepinephrine

Serotonin and Noradrenaline Reuptake Inhibitors

In this open-label randomized controlled intrapatient cross-over study patients are randomly assigned to one of the two treatment groups.

After a one week baseline period, group 1 starts with venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks followed by a two-week wash-out period (no medication), hereafter the group starts with oxybutynin 5 mg twice per day for 6 weeks total.

After a one week baseline period, group 2 starts with oxybutynin 5 mg twice per day for 6 weeks total followed by a two-week wash-out period (no medication), hereafter the group starts with venlafaxine 37.5 mg once daily for 7 days followed by 75mg once daily for 5 weeks.

Oxybutynin 5 mg twice per day for 6 weeks

Venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks

Venlafaxine

Marte Smits, MSc

Lemonitsa Mammatas, PhD

The goal of this randomized intrapatient cross-over study is to assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer.

The objectives it aims to answer are:

* To assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer
* To assess side effects of oxybutynin versus venlafaxine.
* To assess the personal preference of women for oxybutynin versus venlafaxine in reducing hot flashes.
* To assess quality of life of women when reducing hot flashes in women using endocrine therapy after breast cancer.

Participants will fill-out a patient diary during 15 weeks total on a daily basis and receive an (online) questionnaire three times total.

Researchers will compare two groups (venlafaxine group versus oxubutynine group) to assess its efficacy concerning hot flashes.

REDucing Hot FLASHes in Women Using Endocrine Therapy.

A Randomized Intrapatient Cross-over Study to Assess the Efficacy of Oxybutynin Versus Venlafaxine in Reducing Hot Flashes in Women Using Endocrine Therapy After Breast Cancer.

Study protocol, anonymised database and study results may be available on request, after assessment of the reason for request by the study investigators.

Number and severity of hot flashes during 6-weeks of therapy measured by the Hot Flash Diary.

Quality of life and health status at baseline and after 6 weeks of treatment measured by the EORTC-QLQ-C30

Adverse effects of treatments weekly measured by the National Cancer Institute Common Toxicity Criteria scale, version 5

Sleep quality at baseline and after 6 weeks of treatment measured by the Groningen Sleep Quality Scale (GSQ)

Anxiety and depression measured at baseline and after 6 weeks of treatment with the Hospital Anxiety and Depression Scale (HADS)

Sexual function measured at baseline and after 6 weeks of treatment with the Sexual Activity Questionnaire (SAQ)

Cognitive function measured at baseline and after 6 weeks of treatment with the 6-item cognitive impairment test (6-CIT)

Ask patients the following question after 6 weeks of treatment: 'Would you like to continue the endocrine therapy for the recommended duration of therapy taking the current medication (oxybutynin or venlafaxine) given the number and severity of hot flashes you experience during the last week?'

Ask patients the following question after 6 weeks of the final treatment: 'Do you have a preference taking the medication from study period 1 or study period 2?'

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
REDucing Hot FLASHes in Women Using Endocrine Therapy.	NCT06106529	Breast Cancer Hot Flash Due t...	Oxybutynin Venlafaxine	18 Years -	Reinier de Graaf Groep
REDucing Hot FLASHes in Women Using Endocrine Therapy.	NCT06106529	Breast Cancer Hot Flash Due t...	Oxybutynin Venlafaxine	18 Years -	Reinier de Graaf Groep
REDucing Hot FLASHes in Women Using Endocrine Therapy.	NCT06106529	Breast Cancer Hot Flash Due t...	Oxybutynin Venlafaxine	18 Years -	Reinier de Graaf Groep

Spots Global Cancer Trial Database for oxybutynin

Every month we try and update this database with for oxybutynin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for oxybutynin

Every month we try and update this database with for oxybutynin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for oxybutynin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.