REDucing Hot FLASHes in Women Using Endocrine Therapy.

NCT ID: NCT06106529

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-03
• Study Completion Date: 2029-01-01

Brief 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.

Conditions

Breast Cancer; Hot Flash Due to Medication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venlafaxine

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.

Group Type: EXPERIMENTAL

Oxybutynin

Intervention Type: DRUG

Oxybutynin 5 mg twice per day for 6 weeks

Venlafaxine

Intervention Type: DRUG

Venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks

Oxybutynin

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.

Group Type: EXPERIMENTAL

Oxybutynin

Intervention Type: DRUG

Oxybutynin 5 mg twice per day for 6 weeks

Venlafaxine

Intervention Type: DRUG

Venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks

Interventions

Oxybutynin

Oxybutynin 5 mg twice per day for 6 weeks

Intervention Type: DRUG

Venlafaxine

Venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Reinier de Graaf Groep

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lemonitsa Mammatas, PhD

Role: PRINCIPAL_INVESTIGATOR

Reinier De Graaf Ziekenhuis

Locations

Reinier de Graaf Gasthuis

Delft, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Marte Smits, MSc

Role: CONTACT

marte.smits@rdgg.nl

+31152603870

Facility Contacts

Maaike de Leeuw, MSc

Role: primary

M.deLeeuw@rdgg.nl

+31152603035

Other Identifiers

REDFLASH2023-004

Identifier Type: -

Identifier Source: org_study_id