Effects of Acupoint Electro-stimulation on Preventing Nausea and Vomiting Induced by Cisplatin or Oxaliplatin

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00430313
• Date of registration: 30/01/2007
• Primary sponsor: M.D. Anderson Cancer Center
• Public title: Effects of Acupoint Electro-stimulation on Preventing Nausea and Vomiting Induced by Cisplatin or Oxaliplatin
• Scientific title: Effects of Acupoint Electro-stimulation on Preventing Nausea and Vomiting Induced by Cisplatin or Oxaliplatin
• Date of first enrolment: January 2007
• Target sample size: 100
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00430313
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Countries of recruitment

China

Contacts

• Name: Joseph S. Chiang, MD
• Affiliation: UT MD Anderson Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. All patients who will undergo TAI (transarterial infusion) for liver primary or other
primary with liver metastasis

2. Between 18-75 years old

3. Patients who will receive TAI using cisplatin or oxaliplatin

4. Must give informed consent

5. If patient is female and of child bearing potential, must have a negative urine
pregnancy test

Exclusion Criteria:

1. Has local skin infections at or near the acupoints

2. Previous TAI treatment using platinum-based chemotherapy

3. History of cerebrovascular or cardiovascular accident or spinal cord injury

4. Nausea and vomiting induced by intestinal obstruction

5. Has cardiac pacemaker

6. Mental incapacitation or significant emotional or psychiatric disorder that, in the
opinion of the investigator, precludes study entry as these patients may not be able
to cooperate with this slightly invasive procedure or with the data collection
process

7. Currently using acupuncture

8. Vomiting or using 5-HT3 receptor antagonists or other antiemetic in 24 hours before
TAI.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Liver Cancer

Liver Metastasis

Intervention(s)

Procedure: Electro-Stimulation of Yongquan (K1) Acupoint

Primary Outcome(s)

Level of Patient Nausea + Vomiting [Time Frame: 2 Years]

Secondary ID(s)

2006-0735

U19 CA12150301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)