Effectiveness and Safety of Acupuncture for Climacteric Syndrome in Patients With Breast Cancer

NCT ID: NCT01275807

Last Updated: 2015-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Climacteric Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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acupuncture

10 acupuncture sessions

Group Type EXPERIMENTAL

acupuncture

Intervention Type DEVICE

10 sessions of acupuncture

self care

psychological support, phisical exercice, diet, self care groups

Group Type ACTIVE_COMPARATOR

self care

Intervention Type OTHER

physical exercice, diet, self help groups, psychological support

Interventions

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acupuncture

10 sessions of acupuncture

Intervention Type DEVICE

self care

physical exercice, diet, self help groups, psychological support

Intervention Type OTHER

Other Intervention Names

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chinese traditional medicine self help

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Regione Emilia-Romagna

OTHER

Sponsor Role collaborator

Azienda Usl di Bologna

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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grazia lesi, MD

Role: STUDY_DIRECTOR

Bologna Local Health District - Azienda Usl di Bologna

Locations

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Unità operativa (U.O.) salute donna infanzia e adolescenza e Unità operativa Consultori

Bologna, Bologna, Italy

Site Status

Oncologic Medicine, Carpi Hospital

Carpi, Modena, Italy

Site Status

Dipartimento Anestesia, rianimazione, terapia del dolore e comparto operatorio,

Piacenza, , Italy

Site Status

U.O. Medicina Oncologica - Ospedale Santa Maria Nuova Reggio Emilia

Reggio Emilia, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 16428125 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27022113 (View on PubMed)

Other Identifiers

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DGR-2025/2008-Lesi

Identifier Type: -

Identifier Source: org_study_id

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