NCT00425776

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P75+ for phase_1 breast-cancer

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2007

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

2.9 years

First QC Date

January 22, 2007

Last Update Submit

August 20, 2015

Conditions

Breast CancerPostmenopause

Keywords

Breast cancerAcupuncturePost-menopausal hot flushesSe-estradiolSe-endorphine

Outcome Measures

Primary Outcomes (2)

  • using a hot flushes rating scale.

    12 weeks

  • Sleep disturbances yes or no

    12 weeks

Secondary Outcomes (1)

  • Measuring se-estrogen and se-endorhine before and after acupuncture

    12 weeks

Study Arms (3)

Real acupuncture

ACTIVE COMPARATOR
Device: acupuncture

Sham acupuncture

SHAM COMPARATOR
Device: Sham acupuncture

No intervention

NO INTERVENTION

Interventions

acupunctureDEVICE
Also known as: Acupuncture, hot flushes
Real acupuncture
Sham acupunctureDEVICE
Sham acupuncture

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Failing to give consent
  • Any use of estrogen as tablets or plaster

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vejle Hospital

Vejle, Kabbeltoft 25, 7100 Vejle, Denmark

Location

Related Publications (1)

  • Bokmand S, Flyger H. Acupuncture relieves menopausal discomfort in breast cancer patients: a prospective, double blinded, randomized study. Breast. 2013 Jun;22(3):320-3. doi: 10.1016/j.breast.2012.07.015. Epub 2012 Aug 18.

    PMID: 22906948DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Claus Bisgaard, Consultant

    Vejle Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2007

First Posted

January 23, 2007

Study Start

February 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations

DK(1)