Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05331209
Other study ID # BRCA-ACP.2022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date December 31, 2024

Study information

Verified date April 2023
Source Shaare Zedek Medical Center
Contact Noah Samuels, M.D.
Phone +9722666639
Email noahs@szmc.org.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 25 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acupuncture
Weekly acupuncture treatments, for 8 weeks (8 treatments)
Acupuncture-Acupressure
Weekly acupuncture, for 8 weeks, with daily self-acupressure by the patient at home.

Locations

Country Name City State
Israel Center for Integrative Complementary Medicine, Shaare Zedek Medical Center Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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) From end of study intervention (at 8 weeks) to end of post-intervention period (16 weeks)
Secondary 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. Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)
Secondary 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?". Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04587154 - Womens Study to Alleviate Vasomotor Symptoms N/A
Terminated NCT03642119 - Validation of an Objective Instrument to Measure Hot Flashes During Menopause
Completed NCT05061563 - A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults Phase 1
Completed NCT05419908 - Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes Phase 2
Completed NCT01281332 - Mechanical Device for the Relief of Hot Flashes Phase 2
Completed NCT01439945 - Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer Phase 2
Completed NCT00755417 - Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women Phase 3
Completed NCT00599456 - Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women. N/A
Completed NCT01293695 - Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial N/A
Completed NCT00256685 - Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause Phase 3
Completed NCT00391417 - Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms Phase 3
Terminated NCT00244894 - Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer N/A
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Active, not recruiting NCT03580499 - Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy N/A
Recruiting NCT06030388 - Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women N/A
Recruiting NCT04418115 - Fatigue as a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option? N/A
Recruiting NCT04861701 - Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise N/A
Active, not recruiting NCT05086705 - EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer N/A
Completed NCT05099159 - A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2) Phase 3
Completed NCT01140646 - Evaluation of SAMe for Hot Flashes Phase 2