Acupuncture With/Without Self-acupressure for Post-oophorectomy Hot Flashes in BRCA Carriers
NCT ID: NCT05331209
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2026-01-01
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Acupuncture only
Acupuncture treatments will take place at a frequency of once per week, with each session lasting between 30 to 45 minutes. At each session patients will be re-assessed by the study acupuncturist, with acupuncture points individualized in accordance with the principles of traditional Chinese medicine. At the same time, acupuncturists will include a set group of acupuncture points which have been used in the research of hot flashes: HT-6, Kid-3, Liv-3, SP-6.
Acupuncture
Weekly acupuncture treatments, for 8 weeks (8 treatments)
Acupuncture-Acupressure
Weekly acupuncture, for 8 weeks, with daily self-acupressure by the patient at home.
Acupuncture-Acupressure
Patients randomly allocated to the acupuncture-acupressure arm of the study will first be treated by the study acupuncturist in accordance with the protocol described in the Acupuncture arm of the study. At the end of the first session, patients in this group will be taught by the study acupuncturist to self-treat at home with acupressure, on the acupressure points PC-7, ST-36, SP-9. Self-acupressure sessions will last between 3-5 minutes each, and will take place 3-4 times each day. At subsequent acupuncture treatments patients will receive reinforcement and guidance to ensure the fidelity of the self-acupuncture treatments
Acupuncture
Weekly acupuncture treatments, for 8 weeks (8 treatments)
Acupuncture-Acupressure
Weekly acupuncture, for 8 weeks, with daily self-acupressure by the patient at home.
Interventions
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Acupuncture
Weekly acupuncture treatments, for 8 weeks (8 treatments)
Acupuncture-Acupressure
Weekly acupuncture, for 8 weeks, with daily self-acupressure by the patient at home.
Eligibility Criteria
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Inclusion Criteria
* age ≥ 25 years
* after risk-reducing salpingo-oophorectomy
* reporting ≥ 5 hot flashes per day
25 Years
FEMALE
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Noah Samuels
Director, Center for Integrative Complementary Medicine
Locations
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Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BRCA-ACP.2022
Identifier Type: -
Identifier Source: org_study_id
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