Clinical trial • Phase III • Oncology
OXYBUTYNIN for Breast cancer
Phase III trial of OXYBUTYNIN for Breast cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Breast cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 22-12-2023
- First CTIS Authorization Date
- 09-04-2024
Trial design
Randomised, open-label, oxybutynin: 5 mg twice a day; venlafaxine: 37.5 mg once daily during one week, then increase to 75 mg once daily.-controlled, crossover Phase III trial across 4 sites in Netherlands.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Oxybutynin: 5 mg twice a day; Venlafaxine: 37.5 mg once daily during one week, then increase to 75 mg once daily.
- Crossover
- Yes
- Target Sample Size
- 67
- Trial Duration For Participant
- 105
Eligibility
Recruits 67 No vulnerable populations selected; participants are adult women (18 years or older). Subject information and informed consent form available ('L1_CIS and ICF RED FLASH study for publication V4 20250401')..
- Pregnancy Exclusion
- Pregnant;
- Vulnerable Population
- No vulnerable populations selected; participants are adult women (18 years or older). Subject information and informed consent form available ('L1_CIS and ICF RED FLASH study for publication V4 20250401').
Inclusion criteria
- {"criterion_text":"-\tPre-, peri- or postmenopausal women of 18 years or above;"}
- {"criterion_text":"-\tIndication for endocrine therapy and already started with tamoxifen, aromatase inhibitors or luteinizing hormone-releasing hormone analogues for at least 4 weeks and planning to continue for the duration of the study;"}
- {"criterion_text":"-\tExperiencing hot flashes with a minimum of 14 per week for at least 1 month and desire to start a pharmacologic intervention."}
Exclusion criteria
- {"criterion_text":"-\tPregnant;"}
- {"criterion_text":"-\tBreast feeding;"}
- {"criterion_text":"-\tPatients who receive chemotherapy or immunotherapy/HER2 antibodies within the prior 8 weeks, and patients scheduled for chemotherapy during the study period;"}
- {"criterion_text":"-\tPalliative setting;"}
- {"criterion_text":"-\tUse of venlafaxine or any other antidepressants, also including St. John's wort within the previous year;"}
- {"criterion_text":"-\tCreatinine clearance < 30 ml/min;"}
- {"criterion_text":"-\tLiver cirrhosis;"}
- {"criterion_text":"-\tUse of gabapentin and/or calcium channel antagonists within 2 weeks of study entry;"}
- {"criterion_text":"-\tUse of oxybutynin before study entry;"}
- {"criterion_text":"-\tUse of any other substances or therapies for the treatment of hot flashes, for instance acupuncture."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number and severity of hot flashes during 6-week therapy measured by the Hot Flash Diary on a daily basis.","definition_or_measurement_approach":"Measured by the Hot Flash Diary on a daily basis over the 6-week therapy period (number and severity recorded)."}
Secondary endpoints
- {"endpoint_text":"- Adverse events, sleep quality, quality of life, health status, anxiety and depression, cognitive function, sexual function, personal preference, adherence","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 67
- Recruitment Window Months
- 59
- Consent Approach
- Informed consent obtained from participants; subject information and informed consent form available ('L1_CIS and ICF RED FLASH study for publication V4 20250401'). Participants are adults (≥18); no assent described. Languages available not specified.
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 67
Netherlands
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 700
- Number Of Sites
- 4
- Number Of Participants
- 67
Sites
- Site Name
- Alexander Monro Ziekenhuis Stichting
- Department Name
- Oncology
- Contact Person Name
- Monique Crobach
- Contact Person Email
- moniquecrobach@alexandermonro.nl
- Site Name
- Haga Hospital
- Department Name
- Oncology
- Contact Person Name
- Danny Houtsma
- Contact Person Email
- d.houtsma@hagaziekenhuis.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Oncology
- Contact Person Name
- Erik Blok
- Contact Person Email
- e.j.blok@lumc.nl
- Site Name
- Reinier de Graaf Groep
- Department Name
- Oncology
- Contact Person Name
- Lemonitsa Mammatas
- Contact Person Email
- l.mammatas@rdgg.nl
Sponsor
Primary sponsor
- Full Name
- Reinier de Graaf Groep
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- OXYBUTYNIN
- Active Substance
- OXYBUTYNIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Starting Dose
- 5 mg twice a day
- Dose Levels
- 5 mg twice a day
- Frequency
- twice a day
- Maximum Dose
- 10 mg per day
- Investigational Product Name
- VENLAFAXINE
- Active Substance
- VENLAFAXINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Starting Dose
- 37.5 mg once daily
- Dose Levels
- 37.5 mg once daily then increase to 75 mg once daily
- Frequency
- once daily
- Maximum Dose
- 75 mg per day
- Dose Escalation Increase
- 37.5 mg once daily -> 75 mg once daily
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