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A Feasibility Study in Acupuncture for Symptom Management in Palliative Care.


Phase 3
18 Years
N/A
Not Enrolling
Both
Neoplasms, Palliative Care

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Trial Information

A Feasibility Study in Acupuncture for Symptom Management in Palliative Care.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Principal Investigator

Jan T Lim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

BC Cancer Agency and University of British Columbia

Authority:

Canada: Health Canada

Study ID:

BCCAVIC Pal 1

NCT ID:

NCT00302185

Start Date:

June 2007

Completion Date:

March 2008

Related Keywords:

  • Neoplasms
  • Palliative Care
  • Palliative Care
  • Acupuncture
  • Symptom Management
  • Quality of Life
  • Neoplasms

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