Acupuncture in Palliative Cancer Care
キーワード
概要
説明
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.
日付
| 最終確認済み: | 09/30/2010 |
| 最初に提出された: | 03/12/2006 |
| 提出された推定登録数: | 03/12/2006 |
| 最初の投稿: | 03/13/2006 |
| 最終更新が送信されました: | 10/18/2010 |
| 最終更新日: | 10/19/2010 |
| 実際の研究開始日: | 05/31/2007 |
| 一次完了予定日: | 02/29/2008 |
| 研究完了予定日: | 02/29/2008 |
状態または病気
介入/治療
Procedure: Acupuncture
Behavioral: Nurse-led supportive care
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Active Comparator: Nurse-led supportive care Visit with a Palliative Care nurse once weekly for 4 weeks | Behavioral: Nurse-led supportive care 20-30 minutes of supportive attention from an experienced palliative nurse. |
| Experimental: Acupuncture Patients received acupuncture once a week for 4 weeks. | 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. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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 |
結果
主な結果の測定
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 [undefined]
二次的な結果の測定
1. Determine the % of patients suitable, and the % of patients who consent to be recruited. [undefined]
2. Determine the % of patients who complete all 4 intervention sessions. [undefined]
3. Determine the duration of change in ESAS after intervention (ESAS at second and third follow-up - ESAS at first follow up). [undefined]
