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Home > "A" Clinical Trials Conditions > Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer  Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer
Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer
For Condition: Colorectal Neoplasms
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: This study investigates the effect of acupuncture in reducing symptom distress in adults with advanced colon cancer.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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)
Total Enrollment: 170
Location and Contact Information:
Overall Study Official:
EllenRedinbaugh, Principal Investigator, University of Pittsburgh Cancer Institute
University of Pittsburgh Medical Center, Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting
Additional Information:
Study ID Numbers: 1 R01 AT01028-01;
Study Start Date: June 2002
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034034
Other Colorectal Neoplasms Studies:
1. Tezacitabine and oxaliplatin for the treatment of patients with metastatic colorectal cancer
2. First-line treatment of metastatic colorectal cancer with oxaliplatin/5-FU/leucovorin plus PTK787/ZK 222584 or placebo
3. Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen
4. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
5. For Prevention of Diarrhea in Patients Diagnosed with Metastatic Colorectal Cancer Treated with Chemotherapy
Related Studies:
Other Colorectal Neoplasms Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer
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