Acupuncture in Palliative Cancer Care

NCT00302185 | Completed Phase 3

• 1 other identifier: BCCAVIC Pal 1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplasms; Palliative Care

Keywords

Palliative Care; Acupuncture; Symptom Management; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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).

Study Arms (2)

Nurse-led supportive care

ACTIVE COMPARATOR

Visit with a Palliative Care nurse once weekly for 4 weeks

Behavioral: Nurse-led supportive care

Acupuncture

EXPERIMENTAL

Patients received acupuncture once a week for 4 weeks.

Procedure: Acupuncture

Interventions

Acupuncture 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.

Acupuncture

Nurse-led supportive care BEHAVIORAL

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

Nurse-led supportive care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• refuse to receive weekly acupuncture for 4 weeks
• refuse to receive nursing support for 4 weeks
• known to have impaired clotting of blood

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer Agency - Vancouver Island Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jan T Lim, MD

  BC Cancer Agency and University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 13, 2006
• First Posted: March 14, 2006
• Study Start: June 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: October 20, 2010

Record last verified: 2010-10

Locations

CA (1)