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

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ClinicalTrials.gov Identifier: NCT00885183
Recruitment Status : Terminated (Difficult to recruit participants)
First Posted : April 21, 2009
Last Update Posted : July 1, 2019
Sponsor:
Collaborator:
Norwegian Cancer Society
Information provided by (Responsible Party):
University Hospital of North Norway

Study Description
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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 Phase
Breast Cancer Procedure: Acupuncture therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: acupuncture therapy
Breast cancer patients are randomised to additional 12 acupuncture treatment sessions while undergoing standard chemotherapy
 Procedure: Acupuncture therapy
12 acupuncture treatment sessions for a period of 16 weeks
Usual care
Control group (usual care) receives standard chemotherapy alone
 Procedure: Acupuncture therapy
12 acupuncture treatment sessions for a period of 16 weeks


Outcome Measures
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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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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Norway
University Hospital of North Norway
Tromsø, Norway, No-9038
Sponsors and Collaborators
University Hospital of North Norway
Norwegian Cancer Society
Investigators
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Principal Investigator: Sameline Grimsgaard, MD, MPH, PhD Clinical Research Centre, University Hospital of North Norway
More Information
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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: July 1, 2019
Last Verified: June 2019
Keywords provided by University Hospital of North Norway:
breast cancer
chemotherapy
adjuvant therapy
 acupuncture
fatigue
Early stage breast cancer patients
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases