Breast Cancer Clinical Trial
— AcubreastOfficial title:
Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy. A Randomised Controlled Pilot and Feasibility Study
| NCT number | NCT00885183 |
| Other study ID # | REK NORD 77/08 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2009 |
| Est. completion date | June 2014 |
| Verified date | June 2019 |
| Source | University Hospital of North Norway |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 10 |
| Est. completion date | June 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Norway | University Hospital of North Norway | Tromsø |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital of North Norway | Norwegian Cancer Society |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Fatigue scale | Weeks 16 and 29 | ||
| Secondary | Health related quality of life: EORTC QLQ-C30, EORTC QLQ-BR23, MYCaw | Weeks 16, 19 and 29 | ||
| Secondary | Hospital anxiety and depression scale (HADS) | Weeks 16, 19 and 29 |
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