Clinical trial NCT05331209: Acupuncture With/Without Self-acupressure for Post-oophorectomy Hot Flashes in BRCA Carriers
Official title: Acupuncture With or Without Self-acupressure for Hot Flashes in Post-oophorectomy Patients With BRCA Mutations: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hot Flashes
Menopause Surgical
Keywords: acupuncture
acupressure
hot flashes
surgical menopause
quality of life
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, open, randomized, add-on
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hot Flash Score - baseline to 8 weeks
timeFrame: From baseline (at study recruitment) to end of intervention (8 weeks)
Secondary outcomes:
measure: Hot Flash Score - 8 to 16 weeks
timeFrame: From end of study intervention (at 8 weeks) to end of post-intervention period (16 weeks)
measure: Menopause Specific Quality of Life Questionnaire (MenQOL)
timeFrame: Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)
measure: Measure Yourself Concerns and Wellbeing (MYCAW)
timeFrame: Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
Study officials:
References: