Acupuncture With/Without Self-acupressure for Post-oophorectomy Hot Flashes in BRCA Carriers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture, Acupuncture-Acupressure.
- Who it may be relevant to
- Registry conditions: Hot Flashes, Menopause Surgical. Basic parameters: from 25 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Acupuncture With or Without Self-acupressure for Hot Flashes in Post-oophorectomy Patients With BRCA Mutations: A Prospective, Randomized Controlled Trial
Overview
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.
Interventions
- Other Acupuncture
Weekly acupuncture treatments, for 8 weeks (8 treatments) - Other Acupuncture-Acupressure
Weekly acupuncture, for 8 weeks, with daily self-acupressure by the patient at home.
Primary outcome measures
- Hot Flash Score - baseline to 8 weeks [Time frame: From baseline (at study recruitment) to end of intervention (8 weeks)]
Secondary outcome measures (3)
- Hot Flash Score - 8 to 16 weeks [Time frame: From end of study intervention (at 8 weeks) to end of post-intervention period (16 weeks)]
- Menopause Specific Quality of Life Questionnaire (MenQOL) [Time frame: Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)]
- Measure Yourself Concerns and Wellbeing (MYCAW) [Time frame: Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)]
Eligibility criteria
Inclusion criteria
- Female carriers of the BRCA 1 and 2 genes
- age ≥ 25 years
- after risk-reducing salpingo-oophorectomy
- reporting ≥ 5 hot flashes per day
Exclusion criteria
- Patients not fulfilling the study inclusion criteria will be excluded from participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Center for Integrative Complementary Medicine, Shaare Zedek Medical Center — Jerusalem
Identifiers
NCT: NCT05331209 · BRCA-ACP.2022