Ongoing Clinical Trials for Hormone Refractory Breast Cancer
This article provides information about ongoing clinical trials for hormone refractory breast cancer. Currently, there is 1 clinical trial investigating treatments to help manage side effects experienced by women undergoing endocrine therapy after breast cancer. This trial is taking place in the Netherlands and is comparing two medications for reducing hot flashes.
Clinical trial locations
Study on Oxybutynin and Venlafaxine for Reducing Hot Flashes in Women Undergoing Endocrine Therapy After Breast Cancer
This study, known as the RED FLASH study, is designed to help women who have completed breast cancer treatment and are now experiencing hot flashes as a side effect of ongoing endocrine therapy. Hot flashes are sudden feelings of intense warmth that can be disruptive and uncomfortable, affecting daily life and overall well-being.
Main inclusion criteria: The trial is open to women aged 18 or older who are pre-menopausal, peri-menopausal, or post-menopausal. Participants must currently be taking endocrine therapy medications such as tamoxifen, aromatase inhibitors, or luteinizing hormone-releasing hormone analogues for at least 4 weeks, with plans to continue this treatment throughout the study. To qualify, women must be experiencing at least 14 hot flashes per week for a minimum of 1 month and wish to try medication to help manage these symptoms.
Main exclusion criteria: The study excludes women who have any type of cancer other than breast cancer. Only female participants are eligible, as the study is specifically designed for women. Additionally, individuals who are unable to make independent decisions for themselves are not eligible to participate.
Trial focus and goals: The primary aim of the RED FLASH study is to compare the effectiveness of two medications in reducing the number and severity of hot flashes. The trial uses a cross-over design, meaning each participant will receive both treatments at different times during the study period, allowing researchers to directly compare their effects within the same person. Participants will maintain a daily Hot Flash Diary throughout the study to track their symptoms. The study also examines secondary factors including side effects, sleep quality, overall quality of life, and mental health aspects such as anxiety and depression. This comprehensive approach aims to provide valuable information that could improve the quality of life for women dealing with hot flashes after breast cancer treatment.
Investigational drugs: The trial is testing two medications: oxybutynin and venlafaxine. Oxybutynin is a medication typically used to treat overactive bladder symptoms but is being evaluated here for its potential to reduce hot flashes. It works by blocking certain receptors in the body, which helps relax muscles and may influence temperature regulation. Venlafaxine is an antidepressant from the class known as serotonin-norepinephrine reuptake inhibitors (SNRIs). While commonly used for depression and anxiety, it is also known to help manage hot flashes by increasing levels of serotonin and norepinephrine in the brain, which can help reduce the frequency and severity of these symptoms. Both medications are taken orally, and the study will determine which one is more effective for managing hot flashes in this specific patient population.
Summary
Currently, there is one ongoing clinical trial focused on hormone refractory breast cancer, specifically addressing the management of hot flashes in women undergoing endocrine therapy. This trial is taking place in the Netherlands and represents an important effort to improve quality of life for breast cancer survivors dealing with treatment-related side effects. The study’s cross-over design, which allows participants to try both medications, provides a robust method for comparing the effectiveness of oxybutynin and venlafaxine. The comprehensive evaluation includes not only hot flash frequency and severity but also important quality of life factors such as sleep, mental health, and overall well-being. The results of this trial may offer valuable guidance for healthcare providers and patients when choosing treatments to manage hot flashes during post-cancer endocrine therapy.
