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

NCT ID: NCT05331209

Last Updated: 2025-05-16

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hot Flashes Menopause Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, open, randomized, add-on
Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type OTHER

Weekly acupuncture treatments, for 8 weeks (8 treatments)

Acupuncture-Acupressure

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type OTHER

Weekly acupuncture treatments, for 8 weeks (8 treatments)

Acupuncture-Acupressure

Intervention Type OTHER

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)

Intervention Type OTHER

Acupuncture-Acupressure

Weekly acupuncture, for 8 weeks, with daily self-acupressure by the patient at home.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Noah Samuels

Director, Center for Integrative Complementary Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for Integrative Complementary Medicine, Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Noah Samuels, M.D.

Role: CONTACT

+9722666639

Facility Contacts

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Noah Samuels, M.D.

Role: primary

026666395

Other Identifiers

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BRCA-ACP.2022

Identifier Type: -

Identifier Source: org_study_id

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