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Phase 1
35 Years
Not Enrolling
Breast Cancer, Postmenopause

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Trial Information

Breast cancer patients often have a higher prevalance of menopausal symptoms with hor
flushes and sleeping disturbances than women in the general population, and hormone
replacement therapy is not considered suitable for breast cancer patients because an
increase in oestrogen is contraindicated.

There has been some evidence that acupuncture is suitable treatment for hot flushes and
therefore we had a small pilotproject where 25 women treated for breast cancer were given a
course of classical body acupuncture with one 15 min treatment session per week for 5 weeks.
The effekt was remarkable.

We want to prove if this effekt is significantly better than shamacupuncture or to no
treatment at all.

This is a prospective, randomized and doubbleblinded study:

35 women get classical body acupuncture once a week 5 times 35 women get shamacupuncture
once a week 5 times 35 women get no acupuncture. Se-estradiol and se-endorphine will be
measure before start of the first acupuncture and after the first and fifth acupuncture. The
women with no treatment will have blodsamples too in the beginning and at the end of the
fifth week.

Inclusion Criteria:

- Women older than 35 years treated for breastcancer having hot flushes and sleeping
disturbances.It is not allowed to take estrogen as tablets or plaster.

Exclusion Criteria:

- Failing to give consent

- Any use of estrogen as tablets or plaster

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

using a hot flushes rating scale.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Claus Bisgaard, Consultant

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vejle Hospital


Denmark: The Regional Committee on Biomedical Research Ethics

Study ID:




Start Date:

February 2007

Completion Date:

January 2010

Related Keywords:

  • Breast Cancer
  • Postmenopause
  • Breast cancer
  • Acupuncture
  • Post-menopausal hot flushes
  • Se-estradiol
  • Se-endorphine
  • Breast Neoplasms