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

Study Overview
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Brief Summary
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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.

Official Title
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Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy. A Randomised Controlled Pilot and Feasibility Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Acupuncture therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture therapy<br>Breast cancer patients are randomised to additional 12 acupuncture treatment sessions while undergoing standard chemotherapy | Procedure: Acupuncture therapy<br>* 12 acupuncture treatment sessions for a period of 16 weeks<br>|
| Other: Usual care<br>Control group (usual care) receives standard chemotherapy alone | Procedure: Acupuncture therapy<br>* 12 acupuncture treatment sessions for a period of 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue scale |  | Weeks 16 and 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life: EORTC QLQ-C30, EORTC QLQ-BR23, MYCaw |  | Weeks 16, 19 and 29 | 
| Hospital anxiety and depression scale (HADS) |  | Weeks 16, 19 and 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, chemotherapy, adjuvant therapy, acupuncture, fatigue, Early stage breast cancer patients