Clinical trial · Interventional
Acupuncture Treatment of Vasomotor Symptoms in Breast Cancer Patients
Early Acupuncture Treatment of Vasomotor Symptoms and Sleep Disorders in Breast Cancer Luteinising Hormone-releasing Hormone Analogues(LHRHa) Induced Menopause: AcuHOTFLASH Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to evaluate the impact of acupuncture in preventing worsening of hot flashes and sleep disorders in paucisymptomatic premenopausal Breast Cancer (BC) patients undergoing LHRHa plus endocrine therapy. According to the published data, acupuncture is an effective and long-lasting (6 to 8 months) treatment for severe vasomotor symptoms. Treatment response can be affected by different variables, including intervention timing. The main question this study aims to answer is: Can we expect an additional benefit resulting from an early intervention (when patients are still presymptomatic/paucysintomatic) with acupuncture in preventing worsening in terms of frequency/severity of hot flashes and sleep disorders? Researchers will compare patients randomized in two arms: Arm A: intervention with acupuncture Arm B: usual care to see if acupuncture is superior to usual care in preventing worsening of hot flashes
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acupuncture arm
- description
- Intervention with 10 acupuncture sessions twice per week for 4 weeks followed by 2 more sessions once per week
- interventionNames
- Other: Acupuncture
- type
- NO_INTERVENTION
- label
- Usual care arm
- description
- Lifestyle recommendations
Primary outcomes (1)
- measure
- Reduction of frequency and intensity of hot flashes following acupuncture treatment
- timeFrame
- HFCS collected for one week, 6 months following the protocol.
- description
- Hot flashes will be measured by the Hot Flash Composite Score (HFCS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal Breast Cancer patients * Stage I-III breast cancer patients undergoing LHRHa plus ET (tamoxifen or aromatase inhibitors) after surgery * Informed consent Exclusion Criteria: * Ongoing LHRHa during chemotherapy * Ongoing pharmacological therapy or natural products consumption for vasomotor symptoms * Metastatic breast cancer * Ongoing heparin or anticoagulant therapy * Psychiatric conditions
References
Publications (2)
- BACKGROUNDMao JJ, Bowman MA, Xie SX, Bruner D, DeMichele A, Farrar JT. Electroacupuncture Versus Gabapentin for Hot Flashes Among Breast Cancer Survivors: A Randomized Placebo-Controlled Trial. J Clin Oncol. 2015 Nov 1;33(31):3615-20. doi: 10.1200/JCO.2015.60.9412. Epub 2015 Aug 24. PMID 26304905
- BACKGROUNDLesi G, Razzini G, Musti MA, Stivanello E, Petrucci C, Benedetti B, Rondini E, Ligabue MB, Scaltriti L, Botti A, Artioli F, Mancuso P, Cardini F, Pandolfi P. Acupuncture As an Integrative Approach for the Treatment of Hot Flashes in Women With Breast Cancer: A Prospective Multicenter Randomized Controlled Trial (AcCliMaT). J Clin Oncol. 2016 May 20;34(15):1795-802. doi: 10.1200/JCO.2015.63.2893. Epub 2016 Mar 28. PMID 27022113