Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer

NCT ID: NCT00034034

Last Updated: 2007-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2006-08-31

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).

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Acupuncture

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: lead

Principal Investigators

Ellen Redinbaugh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center, Cancer Institute

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

R01AT001028-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT00060073

Identifier Type: -

Identifier Source: nct_alias