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

Официальное название

Acupuncture With or Without Self-acupressure for Hot Flashes in Post-oophorectomy Patients With BRCA Mutations: A Prospective, Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое Acupuncture
  Weekly acupuncture treatments, for 8 weeks (8 treatments)
• Другое Acupuncture-Acupressure
  Weekly acupuncture, for 8 weeks, with daily self-acupressure by the patient at home.

Первичные конечные точки

• Hot Flash Score - baseline to 8 weeks [Срок оценки: From baseline (at study recruitment) to end of intervention (8 weeks)]

Вторичные конечные точки (3)

• Hot Flash Score - 8 to 16 weeks [Срок оценки: From end of study intervention (at 8 weeks) to end of post-intervention period (16 weeks)]
• Menopause Specific Quality of Life Questionnaire (MenQOL) [Срок оценки: Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)]
• Measure Yourself Concerns and Wellbeing (MYCAW) [Срок оценки: Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)]

Критерии участия

Критерии включения

• Female carriers of the BRCA 1 and 2 genes
• age ≥ 25 years
• after risk-reducing salpingo-oophorectomy
• reporting ≥ 5 hot flashes per day

Критерии исключения

• Patients not fulfilling the study inclusion criteria will be excluded from participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Израиль · 1 центр

• Center for Integrative Complementary Medicine, Shaare Zedek Medical Center — Jerusalem

Идентификаторы

NCT: NCT05331209 · BRCA-ACP.2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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