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

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Procedure: Acupuncture therapy

• Registration Number: NCT00885183
• Lead Sponsor: University Hospital of North Norway

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-19
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture therapy	Acupuncture therapy	Breast cancer patients are randomised to additional 12 acupuncture treatment sessions while undergoing standard chemotherapy
Usual care	Acupuncture therapy	Control group (usual care) receives standard chemotherapy alone

Primary Outcome Measures

Name	Time	Method
Fatigue scale	Weeks 16 and 29

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Tromsø, Norway