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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venlafaxine | Experimental | 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. |
|
| Oxybutynin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin | Drug | Oxybutynin 5 mg twice per day for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of hot flashes | Number and severity of hot flashes during 6-weeks of therapy measured by the Hot Flash Diary. | 15 weeks total |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life and health status | Quality of life and health status at baseline and after 6 weeks of treatment measured by the EORTC-QLQ-C30 | 15 weeks total |
| Adverse effects of treatments | Adverse effects of treatments weekly measured by the National Cancer Institute Common Toxicity Criteria scale, version 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marte Smits, MSc | Contact | +31152603870 | marte.smits@rdgg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Lemonitsa Mammatas, PhD | Reinier De Graaf Ziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reinier de Graaf Gasthuis | Recruiting | Delft | South Holland | 2625 AD | Netherlands |
Study protocol, anonymised database and study results may be available on request, after assessment of the reason for request by the study investigators.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C005419 | oxybutynin |
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Venlafaxine |
| Drug |
Venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks |
|
| 15 weeks total |
| Sleep quality | Sleep quality at baseline and after 6 weeks of treatment measured by the Groningen Sleep Quality Scale (GSQ) | 15 weeks total |
| Anxiety and depression | Anxiety and depression measured at baseline and after 6 weeks of treatment with the Hospital Anxiety and Depression Scale (HADS) | 15 weeks total |
| Sexual function | Sexual function measured at baseline and after 6 weeks of treatment with the Sexual Activity Questionnaire (SAQ) | 15 weeks total |
| Cognitive function | Cognitive function measured at baseline and after 6 weeks of treatment with the 6-item cognitive impairment test (6-CIT) | 15 weeks total |
| Adherence | 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?' | 15 weeks total |
| Preference | 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?' | 15 weeks total |
| D017437 |
| Skin and Connective Tissue Diseases |
| Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |