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Acupuncture in Palliative Cancer Care

NCT ID: NCT00302185

Last Updated: 2010-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neoplasms Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nurse-led supportive care

Visit with a Palliative Care nurse once weekly for 4 weeks

Group Type ACTIVE_COMPARATOR

Nurse-led supportive care

Intervention Type BEHAVIORAL

20-30 minutes of supportive attention from an experienced palliative nurse.

Acupuncture

Patients received acupuncture once a week for 4 weeks.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Nurse-led supportive care

20-30 minutes of supportive attention from an experienced palliative nurse.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Columbia Cancer Agency

OTHER

Sponsor Role lead

Responsible Party

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British Columbia Cancer Agency

Principal Investigators

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Jan T Lim, MD

Role: PRINCIPAL_INVESTIGATOR

BC Cancer Agency and University of British Columbia

Locations

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BC Cancer Agency - Vancouver Island Centre

Victoria, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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BCCAVIC Pal 1

Identifier Type: -

Identifier Source: org_study_id