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Stimulation of Auricular Acupuncture-Point for Chemotherapy-Induced Nausea/Vomiting: A Prospective Randomized Double-blind Cross-over Study


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

Stimulation of Auricular Acupuncture-Point for Chemotherapy-Induced Nausea/Vomiting: A Prospective Randomized Double-blind Cross-over Study


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 individual's 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 1/3 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 inclusion/exclusion 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 8.2 package.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

subject

Safety Issue:

No

Principal Investigator

Chih-Hsin Yang, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Deparment of Oncology, National Taiwan University Hospital

Authority:

Taiwan: Department of Health

Study ID:

9561702041

NCT ID:

NCT00360841

Start Date:

June 2006

Completion Date:

July 2010

Related Keywords:

  • Cancer
  • auricular
  • acupuncture
  • Vomiting

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