Hot FlashesBRCANCT05331209
Acupuncture With/Without Self-acupressure for Post-oophorectomy Hot Flashes in BRCA Carriers
A study testing Acupuncture and Acupuncture-Acupressure in people with Hot Flashes and Menopause Surgical, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Hot Flashes, Menopause Surgical
- What is being tested?
- Acupuncture and Acupuncture-Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female carriers of the BRCA 1 and 2 genes
- age ≥ 25 years
- after risk-reducing salpingo-oophorectomy
- reporting ≥ 5 hot flashes per day
Who cannot join
- Patients not fulfilling the study inclusion criteria will be excluded from participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
Jerusalem, 7791031
Noah Samuels, M.D., 026666395, noahs@szmc.org.il
About this study
Official title: Acupuncture With or Without Self-acupressure for Hot Flashes in Post-oophorectomy Patients With BRCA Mutations: A Prospective, Randomized Controlled Trial
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
- Being tested
- Acupuncture, Acupuncture-Acupressure
- Keywords
- acupuncture, acupressure, hot flashes, surgical menopause, quality of life
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Weekly acupuncture treatments, for 8 weeks (8 treatments)
Acupuncture-AcupressureOther
Weekly acupuncture, for 8 weeks, with daily self-acupressure by the patient at home.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Acupuncture; Other: Acupuncture-Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From baseline (at study recruitment) to end of intervention (8 weeks)
Secondary outcomes (3)
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)
Measured: From end of study intervention (at 8 weeks) to end of post-intervention period (16 weeks)
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.
Measured: Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)
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?".
Measured: Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open, randomized, add-on
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noah Samuels, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331209
- Sponsor's protocol ID
- BRCA-ACP.2022
- Acronym
- BRCA
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture With or Without Self-acupressure for Hot Flashes in Post-oophorectomy Patients With BRCA Mutations: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05331209
- Acronym / sponsor ID
- BRCA / BRCA-ACP.2022
- Conditions
- Hot Flashes, Menopause Surgical
- Keywords
- acupuncture, acupressure, hot flashes, surgical menopause, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open, randomized, add-on
| Arm | Type | Receives |
|---|---|---|
| Acupuncture only | Active comparator | Other: Acupuncture, Other: Acupuncture-AcupressureAcupuncture 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-Acupressure | Active comparator | Other: Acupuncture, Other: Acupuncture-AcupressurePatients 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 |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female carriers of the BRCA 1 and 2 genes
- age ≥ 25 years
- after risk-reducing salpingo-oophorectomy
- reporting ≥ 5 hot flashes per day
Key exclusion criteria (1 listed)
- Patients not fulfilling the study inclusion criteria will be excluded from participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureWeekly acupuncture treatments, for 8 weeks (8 treatments) | Other | Acupuncture only, Acupuncture-Acupressure |
| Acupuncture-AcupressureWeekly acupuncture, for 8 weeks, with daily self-acupressure by the patient at home. | Other | Acupuncture only, Acupuncture-Acupressure |
Primary outcome
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)
3 secondary outcomes
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)
Menopause Specific Quality of Life Questionnaire (MenQOL)
Time frame: Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)
Measure Yourself Concerns and Wellbeing (MYCAW)
Time frame: Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Acupuncture-Acupressure in people with Hot Flashes and Menopause Surgical, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noah Samuels, M.D. (+9722666639, noahs@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot Flash Score - baseline to 8 weeks (time frame: From baseline (at study recruitment) to end of intervention (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.