search
Back to results

Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Pittsburgh Medical Center, Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 19, 2002
Last Updated
January 4, 2007
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00034034
Brief Title
Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer
Official Title
An Intervention to Improve End-of-Life Symptom Distress
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
105 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Acupuncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Redinbaugh, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center, Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer

We'll reach out to this number within 24 hrs