Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer

January 4, 2007 updated by: National Center for Complementary and Integrative Health (NCCIH)

An Intervention to Improve End-of-Life Symptom Distress

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center, Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ellen Redinbaugh, PhD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2002

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2002

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01AT001028-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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