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Acupuncture in Palliative Cancer Care

This study has been completed.
Sponsor:
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00302185
First received: March 13, 2006
Last updated: October 19, 2010
Last verified: October 2010

March 13, 2006
October 19, 2010
June 2007
March 2008   (final data collection date for primary outcome measure)
The change in Edmonton Symptom Assessment Score (ESAS) after intervention (ESAS at baseline - ESAS at first follow up) will be analysed for each of the 4 symptoms (fatigue, anxiety, depression, a lack of well-being) under investigation. Results will be
The change in Edmonton Symptom Assessment Score (ESAS) after intervention (ESAS at baseline – ESAS at first follow up) will be analysed for each of the 4 symptoms (fatigue, anxiety, depression, a lack of well-being) under investigation. Results will be
Complete list of historical versions of study NCT00302185 on ClinicalTrials.gov Archive Site
  • Determine the % of patients suitable, and the % of patients who consent to be recruited.
  • Determine the % of patients who complete all 4 intervention sessions.
  • Determine the duration of change in ESAS after intervention (ESAS at second and third follow-up - ESAS at first follow up).
  • Determine the % of patients suitable, and the % of patients who consent to be recruited.
  • Determine the % of patients who complete all 4 intervention sessions.
  • Determine the duration of change in ESAS after intervention (ESAS at second and third follow-up – ESAS at first follow up).
Not Provided
Not Provided
 
Acupuncture in Palliative Cancer Care
A Feasibility Study in Acupuncture for Symptom Management in Palliative Care.

Research question: Can acupuncture improve symptom control and quality of life (QOL) in patients with advanced incurable cancer?

The purposes of this study is to investigate the feasibility of performing a randomized trial with acupuncture in improving symptom control and quality of life (QOL) in patients with advanced incurable cancer at the BC Cancer Agency, Vancouver Island Centre in Victoria.

We will:

  • Evaluate whether subjects who are receiving palliative care for cancer related symptoms can tolerate and complete to a course of acupuncture treatments.
  • Evaluate whether it is possible to conduct a study using acupuncture on cancer patients.

Patients with advanced cancer suffer from many symptoms which dramatically reduce their Quality of Life (QOL). There have been significant improvements in the management of pain, nausea and constipation, but other common symptoms such as fatigue, anxiety, depression, and a lack of well-being are not readily addressed by conventional therapies. As cancer patients usually present with numerous symptoms, it would be important to try to address all of these globally, instead of only treating individual symptoms that respond well to conventional therapy. Attempts at controlling individual symptoms can also give rise to iatrogenic effects. One well known example is constipation occurring in patients who are on opiate analgesics. Successful treatment from the caregiver's perspective is often scored against each individual symptom that is being treated. From the patient's point of view, it is the interplay of the whole treatment package that succeeds or fails in improving his QOL

In an attempt at treating all of the patient's symptoms, research into the use of complementary and alternative medicine (CAM) has been conducted to determine the utility of these treatments in addressing the unmet needs of many patients with cancer. There is preliminary evidence that acupuncture in particular, is successful at improving many cancer and treatment associated symptoms.

Given the potential to improve symptom control and QOL, it is thought that acupuncture should be investigated to assess its effectiveness and feasibility in symptomatic patients with advanced cancer. Acupuncture should be compared against another intervention, so that the control group would also be receiving attention to their symptoms. As supportive care has been shown to be helpful in ameliorating symptoms in terminal care, acupuncture will be compared against this intervention. Sham acupuncture is not considered to be a good comparison for acupuncture as it is not well tested, and its effects are often indistinguishable from acupuncture. Recently however, some studies have reported the use of novel techniques that prevent acupuncture-naïve patients from distinguishing between acupuncture treatment and placebo. These techniques have yet to be independently validated.

Objectives: 1. To determine feasibility of recruiting patients and running a randomized study that involves acupuncture at the BCCA-VIC. 2. To gather enough data to support a grant application to fund a larger study to look at the effectiveness of acupuncture as adjunctive treatment for the management of symptoms associated with palliative cancer care.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neoplasms
  • Palliative Care
  • Procedure: Acupuncture
    Insertion of sterile, single-use acupuncture needles at 10-20 points including PC.6, HT.7, St.36, SP.6, and LR.3. Needles were connected to an electrical stimulator to mimick traditional manual stimulation with alternating patterns of stimulation for 20 minutes.
  • Behavioral: Nurse-led supportive care
    20-30 minutes of supportive attention from an experienced palliative nurse.
  • Active Comparator: Nurse-led supportive care
    Visit with a Palliative Care nurse once weekly for 4 weeks
    Intervention: Behavioral: Nurse-led supportive care
  • Experimental: Acupuncture
    Patients received acupuncture once a week for 4 weeks.
    Intervention: Procedure: Acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients receiving palliative therapy for incurable cancer
  • anticipated survival of at least 3 months
  • able to complete ESAS sheet unaided
  • ESAS of 5 or more in at least one of the following symptoms; fatigue, depression, anxiety and lack of wellbeing

Exclusion Criteria:

  • refuse to receive weekly acupuncture for 4 weeks
  • refuse to receive nursing support for 4 weeks
  • known to have impaired clotting of blood
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00302185
BCCAVIC Pal 1
No
Dr. Jan T. Lim, British Columbia Cancer Agency
British Columbia Cancer Agency
Not Provided
Principal Investigator: Jan T Lim, MD BC Cancer Agency and University of British Columbia
British Columbia Cancer Agency
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP