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

NCT00360841 | Completed Phase 3

• 1 other identifier: 9561702041
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cancer

Keywords

auricular; acupuncture

Outcome Measures

Primary Outcomes (1)

• 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.

  subject

Study Arms (3)

A

EXPERIMENTAL

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; Procedure: Sham auricular acupuncture

B

SHAM COMPARATOR

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; Procedure: Sham auricular acupuncture

C

NO INTERVENTION

No treatment received.

Interventions

Auricular acupuncture PROCEDURE

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.

A; B

Sham auricular acupuncture PROCEDURE

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with known CAD, CVA, epilepsy, hypotension, hypertension

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Oncology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Acupuncture, Ear

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Chih-Hsin Yang, PhD

  Deparment of Oncology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2006
• First Posted: August 7, 2006
• Study Start: June 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 6, 2012

Record last verified: 2012-11

Locations

TW (1)