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

Climacteric Syndrome Clinical Trial

— AcCliMaT  

Official title:

Acupuncture as an Integrated Intervention for the Control of Symptoms of Climacteric Syndrome in Patients Affected by Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275807
• Other study ID #: DGR-2025/2008-Lesi
• Status: Completed
• Phase: Phase 4
• First received: December 30, 2010
• Last updated: September 21, 2015
• Start date: March 2010
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Azienda Usl di Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Climacteric Syndrome
• Syndrome

Intervention

Device:
• acupuncture
10 sessions of acupuncture

Other:
• self care
physical exercice, diet, self help groups, psychological support

Locations

Country	Name	City	State
Italy	Unità operativa (U.O.) salute donna infanzia e adolescenza e Unità operativa Consultori	Bologna
Italy	Oncologic Medicine, Carpi Hospital	Carpi	Modena
Italy	Dipartimento Anestesia, rianimazione, terapia del dolore e comparto operatorio,	Piacenza
Italy	U.O. Medicina Oncologica - Ospedale Santa Maria Nuova Reggio Emilia	Reggio Emilia

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Usl di Bologna	Regione Emilia-Romagna

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Greene climacteric scale	Greene's score as measure for severity of menopausal symptoms. Change in the number of hot flashes.	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.	No