Clinical trial · Interventional
Effectiveness and Safety of Acupuncture for Climacteric Syndrome in Patients With Breast Cancer
Acupuncture as an Integrated Intervention for the Control of Symptoms of Climacteric Syndrome in Patients Affected by Breast Cancer
NCT01275807CI-TRIAL-00019173AcCliMaTcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of the investigators study is to create the evidence of effectivness on climacteric syndrome in patients affected by breast cancer, by acupuncture added to the standard care (self care).
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 |
|---|---|---|---|
| Climacteric Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acupuncture | Device | — | UNRESOLVED |
| self care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- acupuncture
- description
- 10 acupuncture sessions
- interventionNames
- Device: acupuncture
- type
- ACTIVE_COMPARATOR
- label
- self care
- description
- psychological support, phisical exercice, diet, self care groups
- interventionNames
- Other: self care
Primary outcomes (1)
- measure
- Greene climacteric scale
- timeFrame
- baseline ( 14 days before randomization) , between the 5th and 6th session af acupunture(only for experimental arm) at 14 weeks after randomization and at 3 and at 6 month after randomization for both arms.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * breast cancer * thermoregulation symptoms from at least 6-8 weeks - at least 6 hot flushes a day * climateric simptoms * age from 18 to 65 years * spontaneous or caused by chemotherapy amenorrea * hormone therapy for breast cancer * Green climateric scale score = or \> of 15 * performance status Eastern Cooperative Oncology Group (ECOG) \< or = to 1 * the patient agrees to follow physical exercice * diet and self-help groups Exclusion Criteria: * Hormone substitutive Therapy (TOS) during the last month * other systemic treatments for climateric syndrome (tibolone, antidepressants, homeopathy) * chemotherapy or radiotherapy * patients who refuses acupuncture
References
Publications (2)
- BACKGROUNDGupta P, Sturdee DW, Palin SL, Majumder K, Fear R, Marshall T, Paterson I. Menopausal symptoms in women treated for breast cancer: the prevalence and severity of symptoms and their perceived effects on quality of life. Climacteric. 2006 Feb;9(1):49-58. doi: 10.1080/13697130500487224. PMID 16428125
- DERIVEDLesi 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