Breast CancerPhase 3REDFLASHNCT06106529
REDucing Hot FLASHes in Women Using Endocrine Therapy.
A Phase 3 study testing Oxybutynin and Venlafaxine in people with Breast Cancer and Hot Flash Due to Medication, run by Reinier de Graaf Groep at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Hot Flash Due to Medication
- What is being tested?
- Oxybutynin and Venlafaxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Oct 2024to 1 Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-, peri- or postmenopausal women of 18 years or above;
- Indication 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;
- Experiencing hot flashes with a minimum of 14 per week for at least 1 month and desire to start a pharmacologic intervention.
Who cannot join
- Pregnant;
- Breast feeding;
- Patients who receive chemotherapy or immunotherapy/HER2 antibodies within the prior 8 weeks, and patients scheduled for chemotherapy during the study period;
- Palliative setting;
- Use of venlafaxine or any other antidepressants, also including St. John's wort within the previous year;
- Creatinine clearance < 30 ml/min;
Show all 10Show fewer
- Liver cirrhosis;
- Use of gabapentin and/or calcium channel antagonists within 2 weeks of study entry;
- Use of oxybutynin before study entry;
- Use of any other substances or therapies for the treatment of hot flashes, for instance acupuncture.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Reinier de Graaf Gasthuis
Delft, South Holland, 2625 AD
Maaike de Leeuw, MSc, +31152603035, M.deLeeuw@rdgg.nl
Marte Smits, MSc
About this study
Official title: 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.
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:
Read more
- 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.
- Conditions
- Breast Cancer, Hot Flash Due to Medication
- Being tested
- Oxybutynin, Venlafaxine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxybutyninDrug
Oxybutynin 5 mg twice per day for 6 weeks
VenlafaxineDrug
Venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oxybutynin; Drug: Venlafaxine |
| 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. Receives: Drug: Oxybutynin; Drug: Venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of hot flashes
Number and severity of hot flashes during 6-weeks of therapy measured by the Hot Flash Diary.
Measured: 15 weeks total
Secondary outcomes (8)
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
Measured: 15 weeks total
Adverse effects of treatments
Adverse effects of treatments weekly measured by the National Cancer Institute Common Toxicity Criteria scale, version 5
Measured: 15 weeks total
Sleep quality
Sleep quality at baseline and after 6 weeks of treatment measured by the Groningen Sleep Quality Scale (GSQ)
Measured: 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)
Measured: 15 weeks total
Sexual function
Sexual function measured at baseline and after 6 weeks of treatment with the Sexual Activity Questionnaire (SAQ)
Measured: 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)
Measured: 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?'
Measured: 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?'
Measured: 15 weeks total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start3 Oct 2024
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reinier de Graaf Groep
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lemonitsa Mammatas, PhD, Principal investigator, Reinier De Graaf Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106529
- Sponsor's protocol ID
- REDFLASH2023-004
- Acronym
- REDFLASH
- Status last verified
- Jan 2025
- First submitted
- 24 Oct 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, anonymised database and study results may be available on request, after assessment of the reason for request by the study investigators.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06106529
- Acronym / sponsor ID
- REDFLASH / REDFLASH2023-004
- Conditions
- Breast Cancer, Hot Flash Due to Medication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Reinier de Graaf GroepUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 30 Oct 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venlafaxine | Experimental | Drug: Oxybutynin, Drug: VenlafaxineIn 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 | Drug: Oxybutynin, Drug: VenlafaxineAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pre-, peri- or postmenopausal women of 18 years or above;
- Indication 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;
- Experiencing hot flashes with a minimum of 14 per week for at least 1 month and desire to start a pharmacologic intervention.
Key exclusion criteria (10 listed)
- Pregnant;
- Breast feeding;
- Patients who receive chemotherapy or immunotherapy/HER2 antibodies within the prior 8 weeks, and patients scheduled for chemotherapy during the study period;
- Palliative setting;
- Use of venlafaxine or any other antidepressants, also including St. John's wort within the previous year;
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 |
|---|---|---|
| OxybutyninOxybutynin 5 mg twice per day for 6 weeks | Drug | Oxybutynin, Venlafaxine |
| VenlafaxineVenlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks | Drug | Oxybutynin, Venlafaxine |
Primary outcome
Number and severity of hot flashes
Time frame: 15 weeks total
Number and severity of hot flashes during 6-weeks of therapy measured by the Hot Flash Diary.
8 secondary outcomes
Quality of life and health status
Time frame: 15 weeks total
Adverse effects of treatments
Time frame: 15 weeks total
Sleep quality
Time frame: 15 weeks total
Anxiety and depression
Time frame: 15 weeks total
Sexual function
Time frame: 15 weeks total
Cognitive function
Time frame: 15 weeks total
Adherence
Time frame: 15 weeks total
Preference
Time frame: 15 weeks total
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: Yes. 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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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.
Lemonitsa Mammatas, PhD principal investigator
Reinier De Graaf Ziekenhuis
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 and Venlafaxine in people with Breast Cancer and Hot Flash Due to Medication, run by Reinier de Graaf Groep at 1 site in Netherlands.
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 4 Feb 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marte Smits, MSc (+31152603870, marte.smits@rdgg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of hot flashes (time frame: 15 weeks total). 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 4 Feb 2025.