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Acupuncture to Improve Quality of Life in Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00070967
Recruitment Status : Completed
First Posted : October 13, 2003
Last Update Posted : August 18, 2006
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Tracking Information
First Submitted Date  ICMJE October 9, 2003
First Posted Date  ICMJE October 13, 2003
Last Update Posted Date August 18, 2006
Study Start Date  ICMJE September 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Procedure: Acupuncture
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
40
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2005
Primary Completion Date Not Provided
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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00070967
Other Study ID Numbers  ICMJE R21AT001010-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David S. Rosenthal, MD Dana-Farber Cancer Institute
PRS Account National Center for Complementary and Integrative Health (NCCIH)
Verification Date July 2006

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