Vasomotor SymptomsPhase 3NCT05637671
Efficacy and Safety of Oxybutynin Versus Paroxetine in Aromatase Inhibitor-induced Vasomotor Symptoms
A Phase 3 study testing oxybutynin ER and Paroxetine CR in people with Vasomotor Symptoms, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vasomotor Symptoms
- What is being tested?
- oxybutynin ER and Paroxetine CR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2022to Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post-menopausal female patients who are 18 years of age or older.
- Patients diagnosed with hormone receptor-positive breast cancer stage 0 - IIIC (non-advanced breast cancer) who are taking aromatase inhibitors as adjuvant therapy (post-surgery) and having Significant vasomotor symptoms, defined as a mean of 5 moderate to severe hot flashes per day.
- Have an Eastern Cooperative Oncology Group performance status rating (ECOG-PSR) ˂ 2.
- Life expectancy greater than 6 months.
- Normal serum creatinine level and bilirubin level is less than two times the normal level.
- Serum follicle-stimulating hormone (FSH) levels above 40 mIU/mL.
Who cannot join
- Patients taking tamoxifen as adjuvant therapy.
- Metastatic breast cancer.
- Other treatments used for hot flashes, antidepressants, and monoamine oxidase inhibitors (except if they are discontinued for at least one month before study entry).
- Hypersensitivity to paroxetine or oxybutynin.
- Presence of a condition requiring use of an anticholinergic agent.
- Untreated hypertension.
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- Impaired liver or kidney function.
- Unstable cardiac disease.
- Pregnancy or breastfeeding.
- History of self-injurious behavior.
- History of clinical diagnosis or treatment of any psychiatric disorder.
- Prior use of oxybutynin or paroxetine for hot flushes.
- Recent use of oxybutynin or paroxetine for conditions other than vasomotor symptoms unless they are stopped at least 30 days before the study entry.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Dar El-Salam Cancer Hospital
Cairo, Governorate, 11617
alaa el sayed, 01112362822, ealaa46@yahoo.com
About this study
Official title: Efficacy and Safety of Oxybutynin Versus Paroxetine in Breast Cancer Patients With Aromatase Inhibitor-induced Vasomotor Symptoms.
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.
Read more
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.
- Conditions
- Vasomotor Symptoms
- Being tested
- oxybutynin ER, Paroxetine CR
- Keywords
- Hot flashes, vasomotor symptoms, oxybutynin, paroxetine, aromatase inhibitors, breast cancer
- Medical subject headings
- Hot Flashes, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxybutynin ERDrug
One study group will receive 10 mg of oxybutynin ER orally once daily for 12 weeks.
Paroxetine CRDrug
the other group will receive 12.5 mg of paroxetine CR orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| oxybutynin | Active comparator | One study group will receive 10 mg of oxybutynin ER orally once daily for 12 weeks Receives: Drug: oxybutynin ER |
| paroxetine | Active comparator | the other group will receive 12.5 mg of paroxetine CR orally once daily for 12 weeks Receives: Drug: Paroxetine CR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of oxybutynin compared to paroxetine through hot flashes diary
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.
Measured: 12 weeks
Efficacy of oxybutynin compared to paroxetine through The Pittsburgh Sleep Quality Index questionnaire
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.
Measured: 12 weeks
Secondary outcomes (6)
Incidence of Treatment-Emergent Adverse Events
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.).
Measured: 12 weeks
Safety of oxybutynin compared to paroxetine on kidney through serum creatinine assessment
Comparing the safety of oxybutynin to paroxetine on kidney through assessment of serum creatinine abnormalities on week 12 compared to baseline.
Measured: 12 weeks
Safety of oxybutynin compared to paroxetine on kidney through blood urea nitrogen assessment
Comparing the safety of oxybutynin to paroxetine on kidney through assessment of blood urea nitrogen abnormalities on week 12 compared to baseline.
Measured: 12 weeks
Safety of oxybutynin compared to paroxetine on liver through Alanine aminotransferase assessment
Comparing the safety of oxybutynin to paroxetine through assessment of Alanine aminotransferase abnormalities on week 12 compared to baseline.
Measured: 12 weeks
Safety of oxybutynin compared to paroxetine on liver through aspartate aminotransferase assessment
Comparing the safety of oxybutynin to paroxetine through assessment of aspartate aminotransferase abnormalities on week 12 compared to baseline.
Measured: 12 weeks
Safety of oxybutynin compared to paroxetine on liver through bilirubin assessment
Comparing the safety of oxybutynin to paroxetine through assessment of bilirubin abnormalities on week 12 compared to baseline.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start10 Feb 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor SymptomsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa El-Sayed Mohammed Ahmed El-Sewiey, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637671
- Sponsor's protocol ID
- CL(3204)
- Status last verified
- Feb 2023
- First submitted
- 12 Nov 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oxybutynin Versus Paroxetine in Breast Cancer Patients With Aromatase Inhibitor-induced Vasomotor Symptoms.
- ClinicalTrials.gov ID
- NCT05637671
- Acronym / sponsor ID
- CL(3204)
- Conditions
- Vasomotor Symptoms
- Keywords
- Hot flashes, vasomotor symptoms, oxybutynin, paroxetine, aromatase inhibitors, breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxybutynin | Active comparator | Drug: oxybutynin EROne study group will receive 10 mg of oxybutynin ER orally once daily for 12 weeks |
| paroxetine | Active comparator | Drug: Paroxetine CRthe other group will receive 12.5 mg of paroxetine CR orally once daily for 12 weeks |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Post-menopausal female patients who are 18 years of age or older.
- Patients diagnosed with hormone receptor-positive breast cancer stage 0 - IIIC (non-advanced breast cancer) who are taking aromatase inhibitors as adjuvant therapy (post-surgery) and having Significant vasomotor symptoms, defined as a mean of 5 moderate to severe hot flashes per day.
- Have an Eastern Cooperative Oncology Group performance status rating (ECOG-PSR) ˂ 2.
- Life expectancy greater than 6 months.
- Normal serum creatinine level and bilirubin level is less than two times the normal level.
Key exclusion criteria (13 listed)
- Patients taking tamoxifen as adjuvant therapy.
- Metastatic breast cancer.
- Other treatments used for hot flashes, antidepressants, and monoamine oxidase inhibitors (except if they are discontinued for at least one month before study entry).
- Hypersensitivity to paroxetine or oxybutynin.
- Presence of a condition requiring use of an anticholinergic agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxybutynin EROne study group will receive 10 mg of oxybutynin ER orally once daily for 12 weeks. | Drug | oxybutynin |
| Paroxetine CRthe other group will receive 12.5 mg of paroxetine CR orally once daily for 12 weeks. | Drug | paroxetine |
Primary outcome
Efficacy of oxybutynin compared to paroxetine through hot flashes diary
Time frame: 12 weeks
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.
Efficacy of oxybutynin compared to paroxetine through The Pittsburgh Sleep Quality Index questionnaire
Time frame: 12 weeks
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.
6 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: 12 weeks
Safety of oxybutynin compared to paroxetine on kidney through serum creatinine assessment
Time frame: 12 weeks
Safety of oxybutynin compared to paroxetine on kidney through blood urea nitrogen assessment
Time frame: 12 weeks
Safety of oxybutynin compared to paroxetine on liver through Alanine aminotransferase assessment
Time frame: 12 weeks
Safety of oxybutynin compared to paroxetine on liver through aspartate aminotransferase assessment
Time frame: 12 weeks
Safety of oxybutynin compared to paroxetine on liver through bilirubin assessment
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oxybutynin ER and Paroxetine CR in people with Vasomotor Symptoms, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa El-Sayed (01112362822, Alaa.elsewiey@pharma.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of oxybutynin compared to paroxetine through hot flashes diary (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.