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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01275807

Acronym

AcCliMaT

Enrollment

190

Registered

2011-01-12

Start date

2010-03-31

Completion date

2015-09-30

Last updated

2015-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Climacteric Syndrome

Keywords

climacteric, climacteric syndrome

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.

Interventions

DEVICEacupuncture

10 sessions of acupuncture

OTHERself care

physical exercice, diet, self help groups, psychological support

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026