- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00302185
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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British Columbia
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Victoria, British Columbia, 캐나다, V8R 6V5
- BC Cancer Agency - Vancouver Island Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Nurse-led supportive care
Visit with a Palliative Care nurse once weekly for 4 weeks
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20-30 minutes of supportive attention from an experienced palliative nurse.
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실험적: Acupuncture
Patients received acupuncture once a week for 4 weeks.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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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
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2차 결과 측정
결과 측정 |
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Determine the % of patients suitable, and the % of patients who consent to be recruited.
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Determine the % of patients who complete all 4 intervention sessions.
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Determine the duration of change in ESAS after intervention (ESAS at second and third follow-up - ESAS at first follow up).
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jan T Lim, MD, BC Cancer Agency and University of British Columbia
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Nurse-led supportive care에 대한 임상 시험
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University of AlbertaUniversity Hospital Foundation완전한
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University of AlbertaUniversity Hospital Foundation완전한
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VA Office of Research and Development완전한