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Clinical observation of auricular vagus nerve stimulation on the prevention and treatment of cancer chemotherapy-induced nausea and vomiting.

Clinical observation of auricular vagus nerve stimulation on the prevention and treatment of cancer chemotherapy-induced nausea and vomiting.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003262
Enrollment
Unknown
Registered
2013-06-13
Start date
2013-06-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer chemotherapy-induced nausea and vomiting

Interventions

The Drug Group:Drug intravenous injection
The treatment group:Drug intravenous injection and auricular vagus nerve stimulation

Sponsors

Jiangsu Province Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients were included in the study if: 1) they aged from 18 to 75 years old, no limitation for genders; 2) they diagnosed to have malignant tumor based on histological or cytology. The diagnosis of malignant tumors is based on The Common Malignant Tumor Diagnosing and Treating Criteria compiled by the Department of Medical Affairs of People's Republic of China, in addition to case study of pathology; 3) they had chemotherapy indications. Chemotherapy was applied to the selected patients with platinum-contained medicine, and the expected survival period was more than 3 months; 4) they were in good physical condition. The selected patients ought to have Kalou Minkowski score (Karnofsky) >=60; 5) their liver and kidney function: WBC >=4.0*10^9/L, aspartate aminotransferase =80ml/min; 6) they were hospitalized patients in Department of Oncology of Jiangsu Provincial Hospital oncology inpatients had documented medical records; 7) they agreed to sign the consent form and were willing to accept treatment.

Exclusion criteria

Exclusion criteria: Patients were excluded from the study subjects if: 1) they accepted, or planned to accept any other potential or definite antiemetic drugs 24 hours before or 3 days after the study has started; 2) they experienced upper abdomen or head radiotherapy during the period of the chemotherapy has started; 3) they participated in any studies with other medications or any clinical experiments within three months before the study; 4) they had vomiting symptoms within 24 hours before chemotherapy, or had feelings of nausea in line with Level 2 and 3 of the NCI-CTCAE criteria. (Adverse Symptoms Classification); 5) they had liver, kidney or cardiac insufficiency; 6) they were severely infected or suffered from severe hypertension that out of control, or had drug or alcohol abuse; 7) they were clinically proved to have malignant tumors involving the central nervous system; or had gastrointestinal obstruction, complications such as pleural effusion, ascites, or other diseases that are possible to cause nausea or vomiting; 8) they were contraindicated to 5-HT3 receptor antagonist; 9) they had hematological system diseases or other diseases that were unable to receive acupuncture treatment; 10) they were unable to record the daily course of disease, or pregnant, lactating women, person with history of convulsion, or people with abnormal mental status that cannot collaborate.

Design outcomes

Primary

MeasureTime frame
the ratios of the patients in the acute phase without emetic symptom and without rescue medication used;

Secondary

MeasureTime frame
the ratios of the patients of the delay stage;Serum concentration of 5 - HT;

Contacts

Public ContactYinping Wang
wyp-025@163.com+86 13913960615

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026