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

Phase 4

Completed

• Conditions: Climacteric Syndrome
• Interventions: Device: acupuncture; Other: self care

• Registration Number: NCT01275807
• Lead Sponsor: Azienda Usl di Bologna

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-12-30
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-12
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 190

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture	acupuncture	10 acupuncture sessions
self care	self care	psychological support, phisical exercice, diet, self care groups

Primary Outcome Measures

Name	Time	Method
Greene climacteric scale	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.	Greene's score as measure for severity of menopausal symptoms. Change in the number of hot flashes.

Trial Locations

Locations (4)

U.O. Medicina Oncologica - Ospedale Santa Maria Nuova Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

Dipartimento Anestesia, rianimazione, terapia del dolore e comparto operatorio,; 🇮🇹 Piacenza, Italy

Oncologic Medicine, Carpi Hospital; 🇮🇹 Carpi, Modena, Italy

Unità operativa (U.O.) salute donna infanzia e adolescenza e Unità operativa Consultori; 🇮🇹 Bologna, Italy