REDucing Hot FLASHes in Women Using Endocrine Therapy.

Breast Cancer Clinical Trial

— REDFLASH  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06106529
• Other study ID #: REDFLASH2023-004
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 15, 2024
• Est. completion date: January 1, 2029

Study information

• Verified date: February 2024
• Source: Reinier de Graaf Groep
• Contact: Marte Smits, MSc
• Phone: +31152603870
• Email: marte.smits[@]rdgg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hot Flashes

Intervention

Drug:
• Oxybutynin
Oxybutynin 5 mg twice per day for 6 weeks
• Venlafaxine
Venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Reinier de Graaf Groep

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Adverse effects of treatments	Adverse effects of treatments weekly measured by the National Cancer Institute Common Toxicity Criteria scale, version 5	15 weeks total
Secondary	Sleep quality	Sleep quality at baseline and after 6 weeks of treatment measured by the Groningen Sleep Quality Scale (GSQ)	15 weeks total
Secondary	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
Secondary	Sexual function	Sexual function measured at baseline and after 6 weeks of treatment with the Sexual Activity Questionnaire (SAQ)	15 weeks total
Secondary	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
Secondary	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
Secondary	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