The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting

Not Applicable

• Conditions: Lung Neoplasms

• Registration Number: NCT02469493
• Lead Sponsor: Xidian University

Brief Summary

The purpose of this study is to compare the preventive effect of electroacupuncture and sham acupuncture on acute chemotherapy-induced nausea and vomiting and then investigate its potential mechanism by using functional Magnetic Resonance Imaging (fMRI).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-06
• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-11
• Last Update Submitted: 2015-06-18
• Last Update Posted: 2015-06-22
• Primary Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• First diagnosed stage Ⅲ-Ⅳ lung cancer patients on cisplatin chemotherapy;
• Right-handed and aged 18 to 75 years;
• Karnosky performance status (KPS) ≥ 70;
• Life expectancy ≥ 6 months.

Exclusion Criteria

• Had brain metastases or other concurrent life-threatening diseases;
• Nausea and/or vomiting were present 24h before chemotherapy treatment;
• Suffered from or had a history of gastrointestinal diseases;
• Had a history of head trauma, serious neurological or psychiatric disorders;
• Participating in other clinical trials currently;
• Had any contraindication to exposure to a high magnetic field or receive acupuncture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The scores of Rhodes Index of Nausea, Vomiting and Retching.	24 hours

Secondary Outcome Measures

Name	Time	Method
Content of 5-hiaa in urine	12 hours
Heart Rate Variability	1 hour
Tachygastria percentage	1 hour
Dosage of antiemetic drugs	24 hours

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China