REDucing Hot FLASHes in Women Using Endocrine Therapy.

NCT06106529 | Recruiting Phase 3

• 1 other identifier: REDFLASH2023-004
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Quality of life and health status

  15 weeks total

• Adverse effects of treatments

  15 weeks total

• Sleep quality

  15 weeks total

• Anxiety and depression

  15 weeks total

• Sexual function

  15 weeks total

Study Arms (2)

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.

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.

Drug: Oxybutynin; Drug: Venlafaxine

Interventions

Oxybutynin DRUG

Oxybutynin 5 mg twice per day for 6 weeks

Oxybutynin; Venlafaxine

Venlafaxine DRUG

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

Oxybutynin; Venlafaxine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reinier de Graaf Groep: lead

Study Sites (1)

Reinier de Graaf Gasthuis

Delft, South Holland, 2625 AD, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

oxybutynin; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Lemonitsa Mammatas, PhD

  Reinier De Graaf Ziekenhuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marte Smits, MSc

CONTACT

+31152603870; marte.smits@rdgg.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: October 3, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

NL (1)