An Intervention to Improve End-of-Life Symptom Distress
Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer
Sponsors
Source
National Center for Complementary and Integrative Health (NCCIH)
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).
Overall Status
Completed
Start Date
2002-06-01
Completion Date
2006-08-01
Primary Completion Date
N/A
Phase
Phase 1
Study Type
Interventional
Enrollment
105
Condition
Intervention
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)
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Ellen Redinbaugh, PhD |
Principal Investigator |
University of Pittsburgh |
Location
Facility |
|
University of Pittsburgh Medical Center, Cancer Institute Pittsburgh Pennsylvania 15213 United States |
Location Countries
Country
United States
Verification Date
2007-01-01
Lastchanged Date
N/A
Firstreceived Date
N/A
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
, 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 Has Expanded Access
No
Condition Browse
Firstreceived Results Date
N/A
Nct Alias
NCT00060073
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
Single
Study First Submitted
April 19, 2002
Study First Submitted Qc
April 19, 2002
Study First Posted
April 22, 2002
Last Update Submitted
January 4, 2007
Last Update Submitted Qc
January 4, 2007
Last Update Posted
January 5, 2007
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.