Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy. A Randomised Controlled Pilot and Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Fatigue scale
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
acupuncture therapy
Breast cancer patients are randomised to additional 12 acupuncture treatment sessions while undergoing standard chemotherapy
Intervention: Acupuncture therapy (Procedure)
Usual care
Control group (usual care) receives standard chemotherapy alone
Intervention: Acupuncture therapy (Procedure)
Outcomes
Primary Outcomes
Fatigue scale
Time Frame: Weeks 16 and 29
Secondary Outcomes
- Hospital anxiety and depression scale (HADS)(Weeks 16, 19 and 29)
- Health related quality of life: EORTC QLQ-C30, EORTC QLQ-BR23, MYCaw(Weeks 16, 19 and 29)