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Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy (Acubreast)

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.
ClinicalTrials.gov Identifier: NCT00885183
Recruitment Status : Unknown
Verified May 2012 by University Hospital of North Norway.
Recruitment status was:  Recruiting
First Posted : April 21, 2009
Last Update Posted : May 14, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Breast cancer patients report many symptoms while undergoing conventional care, including nausea/vomiting, fatigue, pain, depression and anxiety. Existing interventions to address these common side effects of treatment are limited. Patients diagnosed with cancer frequently seek complementary medicine (CAM), and there is a need to investigate potential effects of CAM therapies. This phased pilot and feasibility study has two aims:

  1. Develop an acupuncture treatment protocol for adjuvant acupuncture care for breast cancer patients undergoing chemotherapy using structured interviews with established acupuncture teams in Norway.
  2. Implement the treatment protocol in a pilot study to evaluate outcome measures, effect sizes and acceptability of acupuncture care delivered alongside conventional care.

Study results will support the design of future research; including a Phase III randomised controlled trial.


Condition or disease Intervention/treatment
Breast Cancer Procedure: Acupuncture therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy. A Randomised Controlled Pilot and Feasibility Study
Study Start Date : April 2009
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: acupuncture therapy
Breast cancer patients are randomised to additional 12 acupuncture treatment sessions while undergoing standard chemotherapy Control group receive standard chemotherapy alone
Procedure: Acupuncture therapy
12 acupuncture treatment sessions for a period of 16 weeks


Outcome Measures

Primary Outcome Measures :
  1. Fatigue scale [ Time Frame: Weeks 16 and 29 ]

Secondary Outcome Measures :
  1. Health related quality of life: EORTC QLQ-C30, EORTC QLQ-BR23, MYCaw [ Time Frame: Weeks 16, 19 and 29 ]
  2. Hospital anxiety and depression scale (HADS) [ Time Frame: Weeks 16, 19 and 29 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females, 18 years or older with early stage breast cancer, no previous chemotherapy and no metastatic disease

Exclusion Criteria:

  • Needle phobia, use of anticoagulant drugs, inability to comply with study regimen
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00885183


Contacts
Contact: Sameline Grimsgaard, MD, MPH, PhD +4777626000 ext 69323 sameline.grimsgaard@unn.no
Contact: Kristin I Jensen, Reg. nurse +47 77626000 ext 69212 kristin.iren.jensen@unn.no

Locations
Norway
University Hospital of North Norway Recruiting
Tromsø, Norway, No-9038
Principal Investigator: Sameline Grimsgaard, MD, MPH, PhD         
Sponsors and Collaborators
University Hospital of North Norway
Norwegian Cancer Society
Investigators
Principal Investigator: Sameline Grimsgaard, MD, MPH, PhD Clinical Research Centre, University Hospital of North Norway
More Information

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00885183     History of Changes
Other Study ID Numbers: REK NORD 77/08
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

Keywords provided by University Hospital of North Norway:
breast cancer
chemotherapy
adjuvant therapy
acupuncture
fatigue
Early stage breast cancer patients

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