Reducing hot flashes in women undergoing endocrine therapy for breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of oxybutynin and venlafaxine in alleviating hot flashes in women who are receiving endocrine therapy after breast cancer treatment. Participants will be randomly assigned to receive either medication and will maintain a daily diary for 15 weeks to track their symptoms and side effects. Additionally, they will complete online questionnaires to assess their personal preferences and quality of life related to the treatment. The study seeks to provide insights into which medication is more effective and better tolerated by patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Reinier de Graaf Gasthuis
  Delft, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Lemonitsa Mammatas, PhD — Reinier De Graaf Ziekenhuis
• Study coordinator: Marte Smits, MSc
• Email: marte.smits@rdgg.nl
• Phone: +31152603870

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gyrotonic exercise for elders with breast cancer and Behcet disease

  We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.

  Recruiting Cairo University · Giza, Dokki · NCT07929116

• PECS II vs SPSIP nerve blocks for pain after mastectomy

  This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.

  Recruiting Bursa City Hospital · Nilufer, Bursa · NCT07929090

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• Compare a new endoscopy-assisted breast-conserving surgery with the usual approach

  This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang and 21 other locations · NCT07920094

• Different skin care approaches to prevent skin reactions after mastectomy radiation

  This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07918989

• 3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy

  This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.

  Recruiting Region Skane · Lund, Skåne County · NCT07916337

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.