Lung Neoplasms
Conditions
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).
Interventions
DEVICEacupuncture (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.
Sponsors
Xidian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The scores of Rhodes Index of Nausea, Vomiting and Retching. | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Content of 5-hiaa in urine | 12 hours |
| Heart Rate Variability | 1 hour |
| Tachygastria percentage | 1 hour |
| Dosage of antiemetic drugs | 24 hours |
Other
| Measure | Time frame |
|---|---|
| Neuroimaging data | 24 hours |
Countries
China
Contacts
Primary ContactJin, Doctor
Outcome results
None listed