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NCT Number: NCT05331209

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

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.

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Key information

Conditions

Hot Flashes Menopause Surgical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Integrative Complementary Medicine, Shaare Zedek Medical Center

Jerusalem, 7791031, Israel

Location contact

Noah Samuels, M.D.

CONTACT

[email protected]

026666395

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

Weekly acupuncture treatments, for 8 weeks (8 treatments)

Acupuncture-Acupressure

Other

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

Primary outcomes

  1. Hot Flash Score - baseline to 8 weeks

    Time frame: From baseline (at study recruitment) to end of intervention (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)

Secondary outcomes

  1. 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)

    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)

  2. Menopause Specific Quality of Life Questionnaire (MenQOL)

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

    The MenQoL study tool assesses health-related quality of life in the immediate postmenopausal period. The tool contains 29 items from four menopausal symptom domains, as experienced over the last month: vasomotor, psychosocial, physical, and sexual. Means are computed for each subscale by dividing the sum of the items in the domain by the number of items within that domain; the final score ranges from 1 to 8.41 For the present study, the questionnaire was translated from English into Hebrew by 2 fully bilingual medical professionals, and then back-translated by 2 other fully bilingual medical professionals, in accordance with acceptable measurement translation methods.

  3. Measure Yourself Concerns and Wellbeing (MYCAW)

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

    The MYCAW (Appendix 2) asks respondents at baseline to list their two main concerns, scoring their severity from a range of 0 (of no concern) to 6 (of greatest concern). Patients are then asked to score the quality of their present level of well-being, from a score of 0 ("as good as it could be") to 6 ("as bad as it could be"). At the follow-up completion of the tool patients are asked once again to score the two primary concerns (listed at baseline), as well as their current perceived level of wellbeing. The follow-up questionnaire then asks respondents to answer two open-ended questions: the first about "other issues related to your health"; and the second, "what has been the most important aspect (of the treatment program) for you?".

Study contacts

Contact information is provided by the study sponsor or research team.

Noah Samuels, M.D.

CONTACT

[email protected]

+9722666639

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study title

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

Acronym: BRCA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 15, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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