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

June 26, 2019 updated by: University Hospital of North Norway

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromsø, Norway, No-9038
        • University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue scale
Time Frame: Weeks 16 and 29
Weeks 16 and 29

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Collaborators

Norwegian Cancer Society

Investigators

  • Principal Investigator: Sameline Grimsgaard, MD, MPH, PhD, Clinical Research Centre, University Hospital of North Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

April 19, 2009

First Submitted That Met QC Criteria

April 20, 2009

First Posted (ESTIMATE)

April 21, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK NORD 77/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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