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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-IOR-14005494 |
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Date of registration:
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2014-11-10 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Acupucture of "Si-Guan points" combined with Fentanyl Transdermal System (duragesic) for the moderate to severe cancer pain: a randomized controled phase III study
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Scientific title:
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Acupucture of "Si-Guan points" combined with Fentanyl Transdermal System (duragesic) for the moderate to severe cancer pain: a randomized controled phase III study |
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Date of first enrolment:
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2014-12-01 |
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Target sample size:
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"Si-Guan Points" combined with Fentanyl Transder:45;Fentanyl Transdermal System (duragesic) Group:45; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=9861 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Lizhu Lin
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Address:
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16 Dayuan Jichang Road, Guangzhou, Guangdong
510000
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Telephone:
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+86 020 36596360 |
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Email:
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lizhulin903@21cn.com |
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Affiliation:
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Name:
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Jietao Lin
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Address:
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16 Dayuan Jichang Road, Guangzhou, Guangdong
510000
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Telephone:
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+86 15813326348 |
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Email:
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linjietao@gmail.com |
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Affiliation:
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The First Affiliated Hospital of Guangzhou University of Chinese Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. without chemotherapy or radiotherapy in 3 weeks;
2. age 18 years or older, gender is not limited;
3. without mental diseases and can evaluate pain;
4. estimated lifetime for 3 months or more;
5. signed informed consent.
Exclusion criteria: 1. the paint is no related to the cancer or the treatment;
2. have difficulty judging pain, mental retardation or mental illness;
3. Children, pregent women or children, pregnant and lactating women;
4. having other severe primary disease;
5. patients with bone metastasis receiving internal radiation therapy and/or receiving bisphosphonates drug therapy receiving within 4 weeks;
6. respiratory depression, (lung) airway obstruction or tissue hypoxia;
7. bile duct diseases;
8. heart disease (heart function level II and level II or above);
9. the blood pressure is higher than normal level;
10. hematological diseases;
11. the liver and renal function abnormal (the index is higher than normal 1 time times);
12. with mental disease who can not judge the pain;
13. fentanyl drug allergy;
14. the drug fentanyl drug tolerance;
15. drug and/or alcohol abuse;
16. pregnant or lactating women;
17. refuse treated with acupuncture and moxibustion.
Age minimum:
18
Age maximum:
80
Gender:
Both
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Health Condition(s) or Problem(s) studied
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cancer pain
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Intervention(s)
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"Si-Guan Points" combined with Fentanyl Transder:Acupucture "Si-Guan Points" combined with Fentanyl Transdermal System (duragesic);Fentanyl Transdermal System (duragesic) Group:Fentanyl Transdermal System (duragesic);
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Primary Outcome(s)
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Numeric rating scale;
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Secondary Outcome(s)
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The Quality of Lif;adverse reaction;The total amount of opiates;
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Source(s) of Monetary Support
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Self-supported
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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