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Completed

NCT Number: NCT01275807

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

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).

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Key information

Conditions

Climacteric Syndrome

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

Device

10 sessions of acupuncture

Other names: chinese traditional medicine

self care

Other

physical exercice, diet, self help groups, psychological support

Other names: self help

Primary outcomes

  1. Greene climacteric scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Collaborators

  • Regione Emilia-Romagna

Registry information

Official study title

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

Acronym: AcCliMaT

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jan 12, 2011
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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