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Acupuncture With/Without Self-acupressure for Post-oophorectomy Hot Flashes in BRCA Carriers

Study acronym: BRCA
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

  1. Notable Primary and study completion dates: Dec 31, 2027 to Dec 31, 2028 Start date: Jan 1, 2026 to Dec 1, 2026v5 Show 1 more changeShow less
    • Start date: Jan 1, 2026 to Dec 1, 2026
  2. Notable Primary and study completion dates: Dec 31, 2024 to Dec 31, 2027 Start date: Nov 1, 2023 to Jan 1, 2026v4 Show 1 more changeShow less
    • Start date: Nov 1, 2023 to Jan 1, 2026
  3. Notable Start date: Feb 1, 2023 to Nov 1, 2023v3
  4. Notable Start date: Jul 1, 2022 to Feb 1, 2023 Primary and study completion dates: Jul 31, 2024 to Dec 31, 2024v2 Show 1 more changeShow less
    • Primary and study completion dates: Jul 31, 2024 to Dec 31, 2024
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Risk-reducing surgery with salpingo-oophorectomy (RRSO) is the standard recommended treatment for all female carriers of BRCA genes 1 and 2. The post-surgical menopause induced is invariably accompanied by hot flashes and other symptoms, which can severely impair quality of life and function. Hormone-replacement therapy (HRT) is the standard conventional treatment for these symptoms, though these drugs do not always provide adequate relief and many patients either cannot receive them due to a diagnosis of breast cancer or hypercoagulable state; or are unwilling to take them due to their concern about the associated increased risk for developing hormone-induced breast cancer. Acupuncture and acupressure have been researched extensively and shown to be both safe and effective in reducing hot flashes in post-menopausal patients and in those with breast cancer receiving anti-hormonal drugs. The present study will examine the effectiveness of acupuncture, with/without self-acupressure, on 200 post- RRSO patients who suffer from at least 5 hot flashes per day, including those treated with HRT. All participants will receive 8 weekly treatments with acupuncture, and then randomly assigned to receive (or not) self-administered acupressure, to be performed daily at home. The response to the study interventions will be assessed using daily Hot Flash Scores, the Menopause Specific Quality of Life (MenQoL) and Measure Yourself Concerns and Wellbeing (MYCAW) questionnaires (at baseline; at the end of the 8-week intervention; and at 16 weeks). The safety of the study treatments will be assessed throughout.
Trial Details
NCT Number NCT05331209
Lead Sponsor Shaare Zedek Medical Center
Conditions Hot Flashes, Menopause Surgical
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov