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NCT Number: NCT06106529

REDucing Hot FLASHes in Women Using Endocrine Therapy.

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Hot Flash Due to Medication Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Reinier de Graaf Gasthuis

Delft, South Holland, 2625 AD, Netherlands

Location status: Recruiting

Location contact

Lemonitsa Mammatas, PHD, MSc

PRINCIPAL_INVESTIGATOR

Maaike de Leeuw, MSc

CONTACT

[email protected]

+31152603035

Marte Smits, MSc

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxybutynin

Drug

Oxybutynin 5 mg twice per day for 6 weeks

Venlafaxine

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Quality of life and health status

    Time frame: 15 weeks total

    Quality of life and health status at baseline and after 6 weeks of treatment measured by the EORTC-QLQ-C30

  2. Adverse effects of treatments

    Time frame: 15 weeks total

    Adverse effects of treatments weekly measured by the National Cancer Institute Common Toxicity Criteria scale, version 5

  3. Sleep quality

    Time frame: 15 weeks total

    Sleep quality at baseline and after 6 weeks of treatment measured by the Groningen Sleep Quality Scale (GSQ)

  4. Anxiety and depression

    Time frame: 15 weeks total

    Anxiety and depression measured at baseline and after 6 weeks of treatment with the Hospital Anxiety and Depression Scale (HADS)

  5. Sexual function

    Time frame: 15 weeks total

    Sexual function measured at baseline and after 6 weeks of treatment with the Sexual Activity Questionnaire (SAQ)

  6. Cognitive function

    Time frame: 15 weeks total

    Cognitive function measured at baseline and after 6 weeks of treatment with the 6-item cognitive impairment test (6-CIT)

  7. Adherence

    Time frame: 15 weeks total

    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?'

  8. Preference

    Time frame: 15 weeks total

    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?'

Study contacts

Contact information is provided by the study sponsor or research team.

Marte Smits, MSc

CONTACT

[email protected]

+31152603870

Sponsors and collaborators

Lead sponsor

Reinier de Graaf Groep

Other

Registry information

Official study 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.

Acronym: REDFLASH

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 30, 2023
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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