NCT01275807

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

5.5 years

First QC Date

December 30, 2010

Last Update Submit

September 21, 2015

Conditions

Climacteric Syndrome

Keywords

climacteric, climacteric syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

acupuncture

EXPERIMENTAL

10 acupuncture sessions

Device: acupuncture

self care

ACTIVE COMPARATOR

psychological support, phisical exercice, diet, self care groups

Other: self care

Interventions

acupunctureDEVICE

10 sessions of acupuncture

Also known as: chinese traditional medicine
acupuncture
self careOTHER

physical exercice, diet, self help groups, psychological support

Also known as: self help
self care

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hormone substitutive Therapy (TOS) during the last month
  • other systemic treatments for climateric syndrome (tibolone, antidepressants, homeopathy)
  • chemotherapy or radiotherapy
  • patients who refuses acupuncture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Bologna, Bologna, 40100, Italy

Location

Oncologic Medicine, Carpi Hospital

Carpi, Modena, Italy

Location

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

Piacenza, Italy

Location

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

Reggio Emilia, Italy

Location

Related Publications (2)

  • 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.

    PMID: 16428125BACKGROUND

  • 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.

    PMID: 27022113DERIVED

MeSH Terms

Interventions

Acupuncture TherapyMedicine, Chinese TraditionalSelf Care

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsMedicine, East Asian TraditionalMedicine, TraditionalRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • grazia lesi, MD

    Bologna Local Health District - Azienda Usl di Bologna

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2010

First Posted

January 12, 2011

Study Start

March 1, 2010

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

IT(4)