Acupuncture to Improve Quality of Life in Patients With Advanced Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

October 9, 2003

Last Updated Date

August 17, 2006

Start Date ^ICMJE

September 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00070967 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Acupuncture to Improve Quality of Life in Patients With Advanced Cancer

Official Title ^ICMJE

Effects of Acupuncture on Pain, Nausea, Quality of Life

Brief Summary

This study will test the feasibility of acupuncture as a complementary therapy for advanced cancer by comparing symptoms and quality of life before and after 8 weeks of acupuncture treatments.

Detailed Description

A large percentage of the practice and use of complementary and alternative medicine (CAM) in the United States is focused on cancer. Whether the CAM use is aimed at reducing one's risk of developing cancer or improving the quality of life of a cancer patient during treatment or at the end of life, the public focus on CAM and cancer has created a driving force for cancer centers to address the efficacy and science of these methods.

Currently, the majority of cancer patients do not receive adequate palliative care. Acupuncture has been shown to be effective in the treatment of pain and nausea and has also been shown to improve one's general well-being. Acupuncture also has some effectiveness in relieving symptoms of anxiety and depression. This study will evaluate the efficacy of acupuncture by Traditional Chinese Medicine clinicians to address the quality of life and symptoms of patients with incurable cancer.

Women with recurrent metastatic ovarian cancer and similar patients with advanced cancer who are ambulatory and receiving conventional palliative care will be enrolled in this study. Patients will continue to receive high-quality, conventional clinical interventions, including chemotherapy and pain and symptom reduction programs. Patients will also receive 8 weeks of acupuncture. Evaluation tools such as Satisfaction with Life Domains Scale for Cancer (SLDS-C), Brief Pain Inventory, and Rotterdam Symptom Check List will be used to assess the acupuncture intervention.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Ovarian Cancer

Intervention ^ICMJE

Procedure: Acupuncture

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria

Advanced cancer patients, primarily ovarian cancer patients
Undergoing palliative care treatment
Ambulatory
Symptomatic with pain, nausea, and/or an inadequate quality of life
Platelets > 25,000/mm3
ANC > 500 cells/mm3

Exclusion Criteria

Acupuncture treatment during the 6 months prior to study entry
History of bleeding disorder, such as hemophilia or von Willebrand disease
Acute psychosis

Gender

Female

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00070967

Responsible Party

Study ID Numbers ^ICMJE

R21 AT001010-01

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David S. Rosenthal, MD

Dana-Farber Cancer Institute

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP