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:
University Hospital of North Norway
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
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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:
- Develop an acupuncture treatment protocol for adjuvant acupuncture care for breast cancer patients undergoing chemotherapy using structured interviews with established acupuncture teams in Norway.
- 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:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Acupuncture
Acute Bronchitis
Anxiety
Breast Cancer
Cancer
Depression
Fatigue
U.S. FDA Resources
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 |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013