Health TrialsbyHealthPanel

REDucing Hot FLASHes in Women Using Endocrine Therapy.

ConditionsBreast CancerHot Flash Due to Medication
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorReinier de Graaf Groep

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: VenlafaxineExperimental treatment 2 interventions
Group B: OxybutyninExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
15 weeks total

Secondary outcomes

1

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

Time frame
15 weeks total
2

Adverse effects of treatments

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

Time frame
15 weeks total
3

Sleep quality

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

Time frame
15 weeks total
4

Anxiety and depression

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

Time frame
15 weeks total

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Reinier de Graaf Groep

Lead sponsor

Source ClinicalTrials.gov
Apply now