Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360841
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2006-08-04
Brief Title:
Stimulation of Auricular Acupuncture-Point for Chemotherapy-Induced NauseaVomiting
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Stimulation of Auricular Acupuncture-Point for Chemotherapy-Induced NauseaVomiting A Prospective Randomized Double-blind Cross-over Study
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate auricular acupuncture as an antiemetic treatment compared with sham acupuncture and with no acupuncture in patients receiving moderately-high to highly emetogenic chemotherapy Acupuncture constitutes a nonpharmacological intervention for chemotherapy-induced nauseavomiting CINV Chinese medicine holds that stimulating select points both on the body and the ear that lie along meridians or life channels can relieve diseases
Detailed Description:
Chemotherapy-induced nausea and vomiting CINV are two of the most commonly reported adverse effects of chemotherapy Uncontrolled CINV reduces quality of life leads to delays in treatment and causes serious metabolic disturbances Current strategies for preventing acute CINV include combination therapy with a 5-HT3 antagonist and a corticosteroid for moderately-high to highly emetogenic chemotherapy Similarly strategies aimed at reducing the incidence and severity of delayed CINV include the combination of a corticosteroid and either a dopamine receptor antagonist or a 5-HT3 antagonist for 3-5 days post chemotherapy Complete protection from vomiting in the first 24 hours is achieved in as many as 70-90 of patients receiving moderately-high and highly emetogenic chemotherapy however standard antiemetics only protect 50 of patients from experiencing nausea during this acute CINV phase Delayed nausea and vomiting is less well defined and controlled with as many as 50 of patients experiencing nausea and vomiting in the 3 to 5 day period following the first day of chemotherapy Both acute and delayed CINV remain a significant problem in patients undergoing high-dose chemotherapy for autologous or allogeneic transplantation where up to 90 of patients experience CINV despite prophylactic strategies Additional pharmacological interventions are clearly needed to optimize control of CINV Neurokinin-1 receptor NK-1 antagonists have been reported to improve the total control rates of acute CINV by approximately 25 compared to the standard combination of a 5-HT3 antagonists and dexamethasone alone Cocquyt et al reported that one dose of a NK-1 antagonist administered prior to cisplatin-based chemotherapy prevented delayed emesis in up to 72 of patients Although promising the role of these agents in CINV prevention and control is as yet undetermined Acupuncture constitutes a nonpharmacological intervention for CINV Chinese medicine holds that stimulating select points both on the body and the ear that lie along meridians or life channels can relieve diseases From the previous studies the P6 point also known as the Neiguan point or G-Jo point no 10 is located 2 cun Chinese inch equivalent to the width of an individuals thumb proximal to the distal wrist crease between the tendons of the palmaris longus and flexor carpi radialis P6 acupuncture was shown to reduce the incidence and severity of nausea and vomiting in the postoperative setting morning sickness and the P6 transcutaneous electrical stimulation TCES therapy was shown to enhance the antiemetic action of ondansetron in patients receiving highly emetic chemotherapy treatment Auricular acupuncture consisted of needle insertion in one ear at four points 1 sympathetic - located in the terminal of the inferior antihelix crus 2 stomach -located around the area where the helix crus terminates 3 shinmoon - located at the bifurcating point between superior and inferior antihelix crus and the lateral 13 of the triangular fossa and 4 occiput - located at the posterior superior corner of the lateral aspect of the antitragus have been reported to be effective in reducing PONV The purpose of this study was to evaluate auricular acupuncture as an antiemetic treatment compared with sham acupuncture and with no acupuncture in patients receiving moderately-high to highly emetogenic chemotherapy
The study is a three group randomized examiner-blind crossover controlled trial It is to evaluate the efficacy and safety of auricular acupuncture in patients receiving moderately-high to highly emetogenic chemotherapy from National Taiwan University Hospital 120 eligible patients receiving moderately-high to highly emetogenic chemotherapy who fulfill the inclusionexclusion criteria and complete the informed consent form will be recruited
After the washout period of 2 weeks the subjects will be required to take the medication for preventing acute CINV including combination therapy with a 5-HT3 antagonist and a corticosteroid for moderately-high to highly emetogenic chemotherapy The patients will be divided into three groups auricular acupuncture treatment group sham auricular acupuncture treatment group and non-treatment group in order to test the effectiveness of auricular acupuncture Group 1 patients will receive no treatment control after completion of the 1st chemotherapy course Group 2 patients will receive auricular acupuncture treatment at the 2nd and 4th chemotherapy courses and will receive sham auricular acupuncture at the 3rd chemotherapy course while Group 3 will receive sham auricular acupuncture at the 2nd and 4th chemotherapy courses and will receive auricular acupuncture at the 3rd chemotherapy course At baseline visit and course 1 2 3 and 4 after chemotherapy every subject will have efficacy evaluations by FILE vomiting visual analog scare WHOQOL-BREF questionnaire and Chinese Disposition Classification Simultaneously they will be monitored on their vital signs complete blood counts urinalysis and biochemical indicators at baseline visit and the end of the trial The collected data will then be analyzed by SAS 82 package
The study is a three group randomized examiner-blind crossover controlled trial It is to evaluate the efficacy and safety of auricular acupuncture in patients receiving moderately-high to highly emetogenic chemotherapy from National Taiwan University Hospital 120 eligible patients receiving moderately-high to highly emetogenic chemotherapy who fulfill the inclusionexclusion criteria and complete the informed consent form will be recruited
After the washout period of 2 weeks the subjects will be required to take the medication for preventing acute CINV including combination therapy with a 5-HT3 antagonist and a corticosteroid for moderately-high to highly emetogenic chemotherapy The patients will be divided into three groups auricular acupuncture treatment group sham auricular acupuncture treatment group and non-treatment group in order to test the effectiveness of auricular acupuncture Group 1 patients will receive no treatment control after completion of the 1st chemotherapy course Group 2 patients will receive auricular acupuncture treatment at the 2nd and 4th chemotherapy courses and will receive sham auricular acupuncture at the 3rd chemotherapy course while Group 3 will receive sham auricular acupuncture at the 2nd and 4th chemotherapy courses and will receive auricular acupuncture at the 3rd chemotherapy course At baseline visit and course 1 2 3 and 4 after chemotherapy every subject will have efficacy evaluations by FILE vomiting visual analog scare WHOQOL-BREF questionnaire and Chinese Disposition Classification Simultaneously they will be monitored on their vital signs complete blood counts urinalysis and biochemical indicators at baseline visit and the end of the trial The collected data will then be analyzed by SAS 82 package
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None