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

This study is currently recruiting participants.
Verified May 2012 by University Hospital of North Norway
Sponsor:
Collaborator:
Norwegian Cancer Society
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00885183
First received: April 19, 2009
Last updated: May 11, 2012
Last verified: May 2012
  Purpose

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 Intervention
Breast Cancer
Procedure: Acupuncture therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Fatigue scale [ Time Frame: Weeks 16 and 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health related quality of life: EORTC QLQ-C30, EORTC QLQ-BR23, MYCaw [ Time Frame: Weeks 16, 19 and 29 ] [ Designated as safety issue: No ]
  • Hospital anxiety and depression scale (HADS) [ Time Frame: Weeks 16, 19 and 29 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00885183     History of Changes
Other Study ID Numbers: REK NORD 77/08
Study First Received: April 19, 2009
Last Updated: May 11, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

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

ClinicalTrials.gov processed this record on April 17, 2014