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Not yet recruitingNCT05331209BRCAUpdated Apr 29, 2026

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

An interventional study of Acupuncture and Acupuncture-Acupressure in Hot Flashes and Menopause Surgical, sponsored by Shaare Zedek Medical Center. Not yet recruiting at 1 site in Israel. Open to female participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Shaare Zedek Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
25 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Hot Flashes
  • Menopause Surgical

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Keywords

  • acupuncture
  • acupressure
  • hot flashes
  • surgical menopause
  • quality of life
03

In context

Hot Flashes

339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.

This study's planned enrollment of 200 is above the median of 90 across 306 interventional studies indexed under Hot Flashes.

Browse Hot Flashes studies →

Lead sponsor

Shaare Zedek Medical Center is the lead sponsor of 195 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients not fulfilling the study inclusion criteria will be excluded from participation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    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.

    Other: Acupuncture · Other: Acupuncture-Acupressure

  • Active comparator
    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

    Other: Acupuncture · Other: Acupuncture-Acupressure

Interventions

  • OtherAcupuncture

    Weekly acupuncture treatments, for 8 weeks (8 treatments)

  • OtherAcupuncture-Acupressure

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

06

What researchers measure

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)

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

Secondary outcomes

  1. Hot Flash Score - 8 to 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)

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

  2. Menopause Specific Quality of Life Questionnaire (MenQOL)

    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.

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

  3. Measure Yourself Concerns and Wellbeing (MYCAW)

    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?".

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

07

Study locations

1 site
  • Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
    Jerusalem, 7791031, Israel
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05331209
Responsible party
Noah Samuels (Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical Center) — Principal investigator
First posted
Apr 15, 2022
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 29, 2026

Study contacts

Noah Samuels, M.D.
Contact
noahs@szmc.org.il
+9722666639

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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