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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University Hospital of North Norway.
Recruitment status was  Recruiting
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
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: 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 August 28, 2014