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Stimulation of Auricular Acupuncture-Point for Chemotherapy-Induced Nausea/Vomiting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00360841
First received: August 4, 2006
Last updated: December 4, 2012
Last verified: November 2012
History of Changes
  Purpose

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 nausea/vomiting (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.


Condition Intervention Phase
Cancer
 Procedure: Auricular acupuncture
Procedure: Sham auricular acupuncture
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Stimulation of Auricular Acupuncture-Point for Chemotherapy-Induced Nausea/Vomiting: A Prospective Randomized Double-blind Cross-over Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • At baseline visit and course 1, 2, 3, and 4 after chemotherapy, every subject will have been efficacy evaluated by FILE, vomiting visual analog scale, WHOQOL-Brief questionnaire and Chinese Disposition Classification. [ Time Frame: subject ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: June 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
The subjects in arms A and B will receive auricular acupuncture. The subjects in arms A will receive auricular acupuncture (at 2nd and 4th chemotherapy courses) as well as the sham auricular acupuncture (at the 3rd chemotherapy course).
 Procedure: Auricular acupuncture
Subjects will be randomized to one of these arms. The subjects in arm A and B will receive auricular acupuncture. Before subjects receive chemotherapy within one day, they will be treated by auricular acupuncture, sham acupuncture, or control group.
Procedure: Sham auricular acupuncture
Sham Comparator: B
The subjects in arms A and B will receive auricular acupuncture. The subjects in arm B will receive the sham auricular acupuncture (at the 2nd and 4th chemotherapy courses) and auricular acupuncture (at the 3rd chemotherapy course).
 Procedure: Auricular acupuncture
Subjects will be randomized to one of these arms. The subjects in arm A and B will receive auricular acupuncture. Before subjects receive chemotherapy within one day, they will be treated by auricular acupuncture, sham acupuncture, or control group.
Procedure: Sham auricular acupuncture
No Intervention: C
No treatment received.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed carcinoma

  • Patients must have normal organ and marrow function as defined below:

    • ANC greater than or equal to 1500/mcL
    • Platelets greater than or equal to 100,000/mcL
    • AST (SGOT)/ALT (SGPT) less than 5 x institutional upper limit of normal
    • Creatinine within normal institutional limits, OR
    • Creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels less than 1.5mg/dl
  • Patients should have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients with known CAD, CVA, epilepsy, hypotension, hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360841

Locations
Taiwan
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chih-Hsin Yang, PhD Deparment of Oncology, National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00360841     History of Changes
Other Study ID Numbers: 9561702041
Study First Received: August 4, 2006
Last Updated: December 4, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
auricular
acupuncture

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013