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


Phase 4
18 Years
65 Years
Open (Enrolling)
Female
Menopausal Syndrome

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Greene climacteric scale

Outcome Description:

Greene's score as measure for severity of menopausal symptoms. Change in the number of hot flashes.

Outcome 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.

Safety Issue:

No

Principal Investigator

grazia lesi, MD

Investigator Role:

Study Director

Investigator Affiliation:

Bologna Local Health District - Azienda Usl di Bologna

Authority:

Italy: Ethics Committee

Study ID:

DGR-2025/2008-Lesi

NCT ID:

NCT01275807

Start Date:

March 2010

Completion Date:

March 2012

Related Keywords:

  • Menopausal Syndrome
  • climacteric, climacteric syndrome
  • Breast Neoplasms

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