Clinical trial NCT01275807: Effectiveness and Safety of Acupuncture for Climacteric Syndrome in Patients With Breast Cancer
Official title: Acupuncture as an Integrated Intervention for the Control of Symptoms of Climacteric Syndrome in Patients Affected by Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Climacteric Syndrome
Keywords: climacteric, climacteric syndrome
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
Collaborators: name: Regione Emilia-Romagna
First posted: 2011-01-12
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: The study will be performed under randomized, open, controlled design. The effect of acupuncture and control group will be compared including the following outcomes: Greene climacteric scale score, quality of life (MenQol italian version), overall improvement in climacteric syndrome, adverse effects from treatment.

Eligibility criteria: 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

Primary outcomes:
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.
Secondary outcomes:
Other outcomes:
Locations:
city: Carpi
country: Italy
facility: Oncologic Medicine, Carpi Hospital
state: Modena
city: Bologna
country: Italy
facility: Unità operativa (U.O.) salute donna infanzia e adolescenza e Unità operativa Consultori
city: Piacenza
country: Italy
facility: Dipartimento Anestesia, rianimazione, terapia del dolore e comparto operatorio,
city: Reggio Emilia
country: Italy
facility: U.O. Medicina Oncologica - Ospedale Santa Maria Nuova Reggio Emilia
Study officials:
affiliation: Bologna Local Health District - Azienda Usl di Bologna
name: grazia lesi, MD
role: STUDY_DIRECTOR
References:
citation: Gupta 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.
citation: Lesi 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.