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

Xidian University

Status: Unknown

Conditions: Lung Neoplasms

Treatments: Device: acupuncture (Huatuo)

Study type: Interventional

Funder types: Other

Identifiers

NCT02469493

2014CB543203

Details and patient eligibility

About

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).

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 4 patient groups

Acupuncture 1

Experimental group

Description:

In this group, patients separately received twice electroacupuncture at bilateral PC6 acupoint before and after Cisplatin administration on the first day of chemotherapy.

Treatment:

Device: acupuncture (Huatuo)

Acupuncture 2

Experimental group

Description:

In this group, patients separately received twice electroacupuncture at bilateral PC6 and RN12 acupoints before and after Cisplatin administration on the first day of chemotherapy.

Treatment:

Device: acupuncture (Huatuo)

Sham acupuncture

Sham Comparator group

Description:

In this group, patients separately received twice electroacupuncture at bilateral nonacupuncture point (S1 located at lateral of flexor carpi radialis, 2 cun above the wrist. S2 located at 3 cun right side of RN12) before and after Cisplatin administration on the first day of chemotherapy.

Treatment:

Device: acupuncture (Huatuo)

Waitinglist control

No Intervention group

Description:

In this group, patients received no electroacupuncture