Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy (Acubreast)
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|ClinicalTrials.gov Identifier: NCT00885183|
Recruitment Status : Unknown
Verified May 2012 by University Hospital of North Norway.
Recruitment status was: Recruiting
First Posted : April 21, 2009
Last Update Posted : May 14, 2012
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:
- Develop an acupuncture treatment protocol for adjuvant acupuncture care for breast cancer patients undergoing chemotherapy using structured interviews with established acupuncture teams in Norway.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Acupuncture therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy. A Randomised Controlled Pilot and Feasibility Study|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||June 2014|
Experimental: acupuncture therapy
Breast cancer patients are randomised to additional 12 acupuncture treatment sessions while undergoing standard chemotherapy Control group receive standard chemotherapy alone
Procedure: Acupuncture therapy
12 acupuncture treatment sessions for a period of 16 weeks
- Fatigue scale [ Time Frame: Weeks 16 and 29 ]
- Health related quality of life: EORTC QLQ-C30, EORTC QLQ-BR23, MYCaw [ Time Frame: Weeks 16, 19 and 29 ]
- Hospital anxiety and depression scale (HADS) [ Time Frame: Weeks 16, 19 and 29 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885183
|Contact: Sameline Grimsgaard, MD, MPH, PhD||+4777626000 ext firstname.lastname@example.org|
|Contact: Kristin I Jensen, Reg. nurse||+47 77626000 ext email@example.com|
|University Hospital of North Norway||Recruiting|
|Tromsø, Norway, No-9038|
|Principal Investigator: Sameline Grimsgaard, MD, MPH, PhD|
|Principal Investigator:||Sameline Grimsgaard, MD, MPH, PhD||Clinical Research Centre, University Hospital of North Norway|