Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
breast cancer, chemotherapy, adjuvant therapy, acupuncture, fatigue, Early stage breast cancer patients
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Acupuncture therapy
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Location
University Hospital of North Norway
Tromsø, Norway
Status: Recruiting
Start Date
April 2009
Completion Date
June 2014
Sponsors
University Hospital of North Norway
Source
University Hospital of North Norway
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page