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

NCT05331209 | Not Yet Recruiting

• 1 other identifier: BRCA-ACP.2022
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hot Flashes; Menopause Surgical

Keywords

acupuncture; acupressure; hot flashes; surgical menopause; quality of life

Outcome Measures

Primary Outcomes (1)

• Hot Flash Score - baseline to 8 weeks

  Hot Flash Score will be calculated by the following equation: Mean number daily hot flashes X mean severity of symptoms (Hot flash severity: 1 - mild; 2 - moderate; 3 - severe)

  From baseline (at study recruitment) to end of intervention (8 weeks)

Secondary Outcomes (3)

• Hot Flash Score - 8 to 16 weeks

  From end of study intervention (at 8 weeks) to end of post-intervention period (16 weeks)

• Menopause Specific Quality of Life Questionnaire (MenQOL)

  Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)

• Measure Yourself Concerns and Wellbeing (MYCAW)

  Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)

Study Arms (2)

Acupuncture only

ACTIVE COMPARATOR

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.

Other: Acupuncture; Other: Acupuncture-Acupressure

Acupuncture-Acupressure

ACTIVE COMPARATOR

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

Other: Acupuncture; Other: Acupuncture-Acupressure

Interventions

Acupuncture OTHER

Weekly acupuncture treatments, for 8 weeks (8 treatments)

Acupuncture only; Acupuncture-Acupressure

Acupuncture-Acupressure OTHER

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

Acupuncture only; Acupuncture-Acupressure

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: The study interventions will be provided to female patients who are carriers of the BRCA 1 and 2 genes who suffer from hot flashes following risk-reducing salpingo-oophorectomy (RRSO). The intervention is not relevant for patients of other genders.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Center for Integrative Complementary Medicine, Shaare Zedek Medical Center

Jerusalem, 7791031, Israel

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Noah Samuels, M.D.

CONTACT

+9722666639; noahs@szmc.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Integrative Complementary Medicine

Model Details: Prospective, open, randomized, add-on

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: April 15, 2022
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)