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

Azienda Usl di Bologna

Status and phase

Completed

Phase 4

Conditions

Climacteric Syndrome

Treatments

Device: acupuncture

Other: self care

Study type

Interventional

Funder types

Other

Identifiers

NCT01275807

DGR-2025/2008-Lesi

Details and patient eligibility

About

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).

Full 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.

Enrollment

190 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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