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

Lung Neoplasms Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02469493
• Other study ID #: 2014CB543203
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2015
• Last updated: June 18, 2015
• Start date: January 2015

Study information

• Verified date: June 2015
• Source: Xidian University
• Contact: Jin, Doctor
• Email: king-jlm[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• First diagnosed stage ?-? 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Device:
• acupuncture (Huatuo)
The needles used were Huatuo brand (Suzhou, China) sterile disposable stainless steel filiform; needles sized 0.25*25 mm. After disinfection, needles were inserted 0.5 to 0.8 inches into the skin and were manipulated manually to obtain Deqi. An electric stimulator (Huatuo SDZ-V, Suzhou, China) was connected to the needles and delivered a constant-current, 0.2-ms, density-wave, stimulus of 2 to 10-Hz frequency, level of intensity was as much as tolerable, but not painful to the subjects. The needles were left for 30 minutes and then removed.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xidian University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neuroimaging data		24 hours	Yes
Primary	The scores of Rhodes Index of Nausea, Vomiting and Retching.		24 hours	Yes
Secondary	Content of 5-hiaa in urine		12 hours	Yes
Secondary	Heart Rate Variability		1 hour	Yes
Secondary	Tachygastria percentage		1 hour	Yes
Secondary	Dosage of antiemetic drugs		24 hours	Yes