Treatment of Hot Flushes in Breast Cancer Patients With Acupuncture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00425776
Recruitment Status : Completed
First Posted : January 23, 2007
Last Update Posted : August 21, 2015
Information provided by (Responsible Party):
Vejle Hospital

Brief Summary:

In a randomized 3-group clinical study acupuncture is used for the relief of menopausal hot flushes and sleep disturbances in women treated for breastcancer.

The three groups consists of 35 women given acupuncture once a week five times and 35 women given shamacupuncture once a week five times and 35 women with no kind of treatment. Se-estradiol and endorphin is measured before and after the acupuncture.

We want to state that acupuncture given five times once a week has a significant better effect on hot flushes and sleeping disturbances than shamacupuncture or no treatment at all.

We also want to measure if there are any changes in se-estradiol and endorphine

Condition or disease Intervention/treatment Phase
Breast Cancer Postmenopause Device: acupuncture Device: Sham acupuncture Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Real acupuncture Device: acupuncture
Other Name: Acupuncture, hot flushes

Sham Comparator: Sham acupuncture Device: Sham acupuncture
No Intervention: No intervention

Primary Outcome Measures :
  1. using a hot flushes rating scale. [ Time Frame: 12 weeks ]
  2. Sleep disturbances yes or no [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Measuring se-estrogen and se-endorhine before and after acupuncture [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00425776

Vejle Hospital
Vejle, Kabbeltoft 25, Denmark, 7100 Vejle
Sponsors and Collaborators
Vejle Hospital
Principal Investigator: Claus Bisgaard, Consultant Vejle Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vejle Hospital Identifier: NCT00425776     History of Changes
Other Study ID Numbers: K07-01
First Posted: January 23, 2007    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015

Keywords provided by Vejle Hospital:
Breast cancer
Post-menopausal hot flushes

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases