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Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00034034
First Posted: April 22, 2002
Last Update Posted: January 5, 2007
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.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: An Intervention to Improve End-of-Life Symptom Distress

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT00034034


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center, Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Ellen Redinbaugh, PhD University of Pittsburgh
  More Information

ClinicalTrials.gov Identifier: NCT00034034     History of Changes
Obsolete Identifiers: NCT00060073
Other Study ID Numbers: R01AT001028-01 ( U.S. NIH Grant/Contract )
First Submitted: April 19, 2002
First Posted: April 22, 2002
Last Update Posted: January 5, 2007
Last Verified: January 2007

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
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

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases