N/A
Completed N=78
Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial
Source: ClinicalTrials.gov NCT03783546 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10 — -5.3; -0.5 HFS score on a scale — p=0.0003
Summary
This research study is evaluating acupuncture, a medical therapy in which hair-thin, stainless steel needles are shallowly inserted into specific points to help the body's natural healing process, as a possible treatment to reduce hot flashes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10 |
-5.3; -0.5 | 0.0003 sig |
| SECONDARY Changes in the Total and Subscores in Functional Assessment of Cancer Therapy- Breast Cancer |
6.6; -1.9 | — |
| SECONDARY Changes in the Endocrine Symptom Subscale (ESS) in Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES) |
5.3; -0.5 | 0.002 sig |
Eligibility Criteria
Inclusion Criteria
- History of histologically or cytologically proven Stage I-III breast cancer with estrogen receptor positive with HER-2 positive or negative tumor;
- Premenopausal or postmenopausal status;
- Completed all primary chemotherapy and surgery;
- Currently undergoing adjuvant hormonal therapy (e.g. Tamoxifen and/or Aromatase inhibitors) with or without ovarian function suppression for at least 4 weeks at study entry; the use of Trastuzumab after adjuvant chemotherapy is allowed;
- Reported persistent hot flashes for at least 4 weeks AND more than 14 episodes of hot flashes per week (2 hot flashes per day) during the week prior to the study entry;
- Age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Signed informed consent
Exclusion Criteria
Undergoing chemotherapy or planned surgery, chemotherapy, change doses and regimen of hormonal therapy during the study period;
- Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
- Uncontrolled seizure disorder or history of seizure;
- Active clinically significant uncontrolled infection;
- Use of acupuncture for hot flashes within 6 months prior to the study entry;
- Uncontrolled major psychiatric disorders, such as major depression or psychosis;
- Newly starting pharmacologic treatment of hot flashes such as selective serotonin reuptake inhibitors (SSRIs) and/or anti-convulsant for less than 4 weeks prior to study entry. Participants may continue with medications or therapies for the treatment of hot-flashes while participating in the study if the medication has been taking for more than 4 weeks prior to study entry AND the dose of the medication is going to be kept consistently during the study
Data sourced from ClinicalTrials.gov (NCT03783546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.