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Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer

This study has been completed.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00034034
  Purpose

This study investigates the effect of acupuncture in reducing symptom distress in adults with advanced colon cancer.


Condition Intervention Phase
Colorectal Neoplasms
Procedure: Acupuncture
Phase I

MedlinePlus related topics:   Acupuncture    Cancer    Colorectal Cancer   

Drug Information available for:   Epinephrine    Epinephrine bitartrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title:   An Intervention to Improve End-of-Life Symptom Distress

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:   105
Study Start Date:   June 2002
Estimated Study Completion Date:   August 2006

Detailed Description:

End-stage colorectal cancer is associated with physical and psychological symptoms that negatively affect patients' quality of life (QOL). Nonpharmacological interventions that promote relaxation and reduce psychological distress are associated with a reduction of pain suggesting that psychological distress and anxiety may mediate the relationship between symptom severity and QOL. Pilot data from a sample of 28 end-stage cancer patients supports the mediational role of psychological distress in the symptom severity - QOL relationship. The results indicated that the mere presence or absence of a physical symptom is not related to patient QOL. Rather, greater symptom severity was associated with significantly poorer QOL, and when the effects of psychological distress were controlled, the relationships between symptom severity and QOL were no longer significant. The proposed research focuses on psychological distress as an underlying mechanism of physical symptom severity among EOL cancer patients and a non-traditional approach (acupuncture) to relieving distress and symptom severity. Acupuncture has been used successfully with end-of-life populations (EOL) to reduce pain and shortness of breath [4]. Patients with psychological distress report the greatest benefit from acupuncture. Rather than using acupuncture to treat pain and discomfort, the proposed research will evaluate acupuncture that targets acupoints associated with anxiety and emotional well-being. One hundred seventy patients with metastatic colorectal cancer will be recruited for the study through the University of Pittsburgh Cancer Institute (UPCI).

Participating patients will be randomized into one of three conditions: 1) a "true" acupuncture condition, 2) a "sham" acupuncture condition, and 3) a usual care control group. Assessment procedures will gather demographic, QOL, physical and psychological symptomatology, medication use, and salivary cortisol data. Randomization will occur after baseline assessment, and participants randomized to one of the two intervention conditions will receive acupuncture treatments three times a week for four weeks. Follow-up assessments will occur weekly for four weeks following the intervention. The proposed study will 1) test the efficacy of an acupuncture intervention in reducing psychological distress and physical symptom severity and 2) examine acupuncture's role in regulating stress responses associated with hypothalamic-pituitary axis (HPA) activity. Findings from this study will 1) promote our understanding of psychological distress as a mechanism of physical symptom distress, and 2) promote the integration of Eastern healing philosophies (acupuncture) with the Western medical model (stress-related HPA activation).

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion criteria:

  • Advanced colon cancer that has not responded to two rounds of chemotherapy
  • Speak, read, write English
  • Live within a 50 mile radius of Pittsburgh, PA
  • Not taking any steroid medication
  • A platelet count of 75,000 or greater
  • Never had acupuncture before

Exclusion Criteria:

  • Allergy to stainless steal
  • Implanted pacemaker
  • Current skin infection
  • Needle phobia
  • Metastatic disease to the central nervous system (brain, spinal cord)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034034

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center, Cancer Institute    
      Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Investigators
Principal Investigator:     Ellen Redinbaugh, PhD     University of Pittsburgh    
  More Information


Study ID Numbers:   R01 AT001028-01
First Received:   April 19, 2002
Last Updated:   January 4, 2007
ClinicalTrials.gov Identifier:   NCT00034034
Health Authority:   United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Advanced colorectal cancer  
acupressure /acupuncture  
anxiety  
colorectal neoplasm  
human therapy evaluation  
neoplasm /cancer palliative treatment  
quality of life  
terminal patient care  
hypothalamic pituitary adrenal axis
pain
psychological aspect of cancer
stress management
alternative medicine
behavioral /social science research tag
human subject
patient oriented research

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Stress
Quality of Life
Pain
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Epinephrine
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 24, 2008




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