Study on Oxybutynin and Venlafaxine for Reducing Hot Flashes in Women Undergoing Endocrine Therapy After Breast Cancer

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What is this study about?

The RED FLASH study is focused on helping women who have had breast cancer and are experiencing hot flashes as a side effect of their ongoing treatment. Hot flashes are sudden feelings of warmth, often intense, that can occur in women undergoing endocrine therapy after breast cancer. This study is comparing two treatments: oxybutynin and venlafaxine. Oxybutynin is usually used to treat bladder issues, while venlafaxine is commonly used as an antidepressant. Both medications are being tested to see how well they can reduce the number and severity of hot flashes.

The purpose of the study is to find out which of these two medications is more effective in reducing hot flashes. Participants will receive both treatments at different times during the study, allowing researchers to compare the effects within the same individual. This approach is known as a “cross-over” study. The study will last for several weeks, during which participants will take one medication for a period, then switch to the other. Throughout the study, participants will keep a daily record of their hot flashes in a Hot Flash Diary.

In addition to tracking hot flashes, the study will also look at other factors such as any side effects, sleep quality, overall quality of life, and mental health aspects like anxiety and depression. The study aims to provide valuable information that could help improve the quality of life for women dealing with hot flashes after breast cancer treatment.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that you are a pre-, peri-, or postmenopausal woman aged 18 or above, currently undergoing endocrine therapy with tamoxifen, aromatase inhibitors, or luteinizing hormone-releasing hormone analogues for at least 4 weeks, and experiencing at least 14 hot flashes per week for a minimum of 1 month.

2 randomization and treatment assignment

You will be randomly assigned to receive either oxybutynin or venlafaxine to manage hot flashes. Oxybutynin is taken orally, while venlafaxine is also administered orally.

3 treatment phase

The treatment phase lasts for 6 weeks. During this time, you will take the assigned medication as directed. The specific dosage and frequency will be provided by the study team.

4 daily hot flash diary

Throughout the 6-week treatment phase, you will be required to maintain a daily diary to record the number and severity of hot flashes. This information is crucial for assessing the effectiveness of the treatment.

5 evaluation of primary and secondary endpoints

The primary endpoint is the number and severity of hot flashes, which will be evaluated using the data from your hot flash diary. Secondary endpoints include monitoring for any adverse events, assessing sleep quality, quality of life, health status, anxiety and depression, cognitive function, sexual function, personal preference, and adherence to the treatment.

6 cross-over phase

After the initial 6-week treatment phase, you may switch to the alternative medication (from oxybutynin to venlafaxine or vice versa) for another 6-week period, following the same procedures as the initial phase.

7 final assessment

At the end of the study, a final assessment will be conducted to evaluate the overall effectiveness of the treatments and gather your feedback on personal preference and adherence.

Who Can Join the Study?

Women who are either before menopause, going through menopause, or have completed menopause and are 18 years or older.
Women who need to take endocrine therapy (a treatment that blocks or removes hormones) and have already started taking medications like tamoxifen, aromatase inhibitors, or luteinizing hormone-releasing hormone analogues for at least 4 weeks. They should plan to continue these medications during the study.
Women who experience hot flashes (sudden feelings of warmth, often over the face, neck, and chest) at least 14 times a week for at least 1 month and want to start taking medication to help with this.

Who Cannot Join the Study?

Participants must not have any other type of cancer besides breast cancer.
Participants should not be male, as the study is only for females.
Participants must not be part of a vulnerable population, which means they should not be in a situation where they are unable to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Reinier de Graaf Groep	Delft	The Netherlands
Ledwa Uvfjglvkvzlk Mmxnxfc Cgxpnio (gddjn	Leiden	The Netherlands
Asqyoywvq Mjdql Zpgsfqgxkv Sxdcsmvxg	Bilthoven	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	08.01.2024

Trial locations

Investigated drugs:

Oxybutynin is a medication commonly used to treat symptoms of overactive bladder, such as frequent or urgent urination. In this trial, it is being tested for its ability to reduce hot flashes in women who are undergoing endocrine therapy after breast cancer treatment. The goal is to see if it can help manage these uncomfortable symptoms.

Venlafaxine is an antidepressant that belongs to a class of medications known as serotonin-norepinephrine reuptake inhibitors (SNRIs). It is often used to treat depression and anxiety disorders. In this study, venlafaxine is being evaluated for its effectiveness in reducing hot flashes in women receiving endocrine therapy after breast cancer. The trial aims to determine if venlafaxine can provide relief from these symptoms.

Investigated diseases:

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some tumors growing slowly and others more rapidly. Hormonal, genetic, and environmental factors can influence its development. Symptoms may include changes in breast shape, skin dimpling, or nipple discharge. Early detection through screening can help manage the disease more effectively.

Trial ID:

2023-507847-13-00

NCT ID:

NCT06106529

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Oxybutynin and Venlafaxine for Reducing Hot Flashes in Women Undergoing Endocrine Therapy After Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?