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Clinical Trials/NCT00885183
NCT00885183TerminatedNot Applicable

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

University Hospital of North Norway2 sites in 1 country10 target enrollmentStarted: April 1, 2009Last updated:
Conditions
Interventions

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:

  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.

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

Experimental

Breast cancer patients are randomised to additional 12 acupuncture treatment sessions while undergoing standard chemotherapy

Intervention: Acupuncture therapy (Procedure)

Usual care

Other

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)

Investigators

Sponsor
University Hospital of North Norway
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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