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

NCT00885183 | Terminated

• 1 other identifier: REK NORD 77/08
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 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. 2.Implement the treatment protocol in a pilot study to evaluate outcome measures, effect sizes and acceptability of acupuncture care delivered alongside conventional care.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fatigue scale

  Weeks 16 and 29

Secondary Outcomes (2)

• 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

Study Arms (2)

acupuncture therapy

EXPERIMENTAL

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

Procedure: Acupuncture therapy

Usual care

OTHER

Control group (usual care) receives standard chemotherapy alone

Procedure: Acupuncture therapy

Interventions

Acupuncture therapy PROCEDURE

12 acupuncture treatment sessions for a period of 16 weeks

Usual care; acupuncture therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females, 18 years or older with early stage breast cancer, no previous chemotherapy and no metastatic disease

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• Norwegian Cancer Society: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, No-9038, Norway

Location

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Sameline Grimsgaard, MD, MPH, PhD

  Clinical Research Centre, University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2009
• First Posted: April 21, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: July 1, 2019

Record last verified: 2019-06

Locations

NO (1)