Treatment of Hot Flushes in Breast Cancer Patients With Acupuncture

This study has been completed.
Sponsor:
Information provided by:
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT00425776
First received: January 22, 2007
Last updated: January 11, 2010
Last verified: January 2007
  Purpose

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 Intervention Phase
Breast Cancer
Postmenopause
Device: acupuncture
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • using a hot flushes rating scale. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Sleep disturbances yes or no [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measuring se-estrogen and se-endorhine before and after acupuncture [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 105
Study Start Date: February 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
One group get real acupuncture
Device: acupuncture

1 group get real acupuncture

1 group get sham acupuncture

1 group get no kind of acupuncture

Other Name: Acupuncture, hot flushes
Sham Comparator: 2
one group get sham acupuncture
Device: acupuncture

1 group get real acupuncture

1 group get sham acupuncture

1 group get no kind of acupuncture

Other Name: Acupuncture, hot flushes
No Intervention: 3
one group get no kind of acupuncture
Device: acupuncture

1 group get real acupuncture

1 group get sham acupuncture

1 group get no kind of acupuncture

Other Name: Acupuncture, hot flushes

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425776

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

No publications provided by Vejle Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Managing Consultant Vagn Berg, Vejle Hospital
ClinicalTrials.gov Identifier: NCT00425776     History of Changes
Other Study ID Numbers: K07-01
Study First Received: January 22, 2007
Last Updated: January 11, 2010
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Vejle Hospital:
Breast cancer
Acupuncture
Post-menopausal hot flushes
Se-estradiol
Se-endorphine

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

ClinicalTrials.gov processed this record on October 23, 2014