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TerminatedNCT00885183AcubreastUpdated Jul 1, 2019

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

An interventional study of Acupuncture therapy in Breast Cancer, sponsored by University Hospital of North Norway. Terminated at 1 site in Norway. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-01.

Sponsored by University Hospital of North Norway · Not applicable, Interventional, and Supportive care

Why this study was terminated
Difficult to recruit participants
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer
  • chemotherapy
  • adjuvant therapy
  • acupuncture
  • fatigue
  • Early stage breast cancer patients
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 10 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University Hospital of North Norway is the lead sponsor of 150 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Needle phobia, use of anticoagulant drugs, inability to comply with study regimen
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    acupuncture therapy

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

    Procedure: Acupuncture therapy

  • Other
    Usual care

    Control group (usual care) receives standard chemotherapy alone

    Procedure: Acupuncture therapy

Interventions

  • ProcedureAcupuncture therapy

    12 acupuncture treatment sessions for a period of 16 weeks

06

What researchers measure

Primary outcomes

  1. Fatigue scale

    Time frame: Weeks 16 and 29

Secondary outcomes

  1. Health related quality of life: EORTC QLQ-C30, EORTC QLQ-BR23, MYCaw

    Time frame: Weeks 16, 19 and 29

  2. Hospital anxiety and depression scale (HADS)

    Time frame: Weeks 16, 19 and 29

07

Study locations

1 site
  • University Hospital of North Norway
    Tromsø, No-9038, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00885183
Lead sponsor
University Hospital of North Norway
Collaborators
Norwegian Cancer Society
Responsible party
Sponsor
First posted
Apr 21, 2009
Start date
Apr 2009
Primary completion
Dec 2013
Completion
Jun 2014
Last update
Jul 1, 2019

Study contacts

Sameline Grimsgaard, MD, MPH, PhD
principal investigator · Clinical Research Centre, University Hospital of North Norway

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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