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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00885183
Acronym
Acubreast
Enrollment
10
Registered
2009-04-21
Start date
2009-04-30
Completion date
2014-06-30
Last updated
2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, chemotherapy, adjuvant therapy, acupuncture, fatigue, Early stage breast cancer patients

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: 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.

Interventions

PROCEDUREAcupuncture therapy

12 acupuncture treatment sessions for a period of 16 weeks

Sponsors

Norwegian Cancer Society
CollaboratorOTHER
University Hospital of North Norway
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Fatigue scaleWeeks 16 and 29

Secondary

MeasureTime frame
Health related quality of life: EORTC QLQ-C30, EORTC QLQ-BR23, MYCawWeeks 16, 19 and 29
Hospital anxiety and depression scale (HADS)Weeks 16, 19 and 29

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026