Trial Information

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

Nausea and vomiting are common side effects caused by chemotherapy. Some studies have shown
that acupuncture can be helpful in treating nausea and vomiting. Acupuncture uses very thin
needles inserted at certain points on the body that are believed to affect bodily functions.
Researchers want to study the effects on nausea and vomiting of giving electro-stimulation
(using wires attached to the body to provide very small electrical shocks to the skin) to an
acupuncture site, compared to giving electro-stimulation to a inactive site (a site that
does not respond to acupuncture).

Before you can start treatment on this study, you will have screening tests. These tests
will help the doctor decide if you are eligible to take part in this study. Your complete
medical history will be recorded. You will have a physical exam, including measurement of
your vital signs (blood pressure, heart rate, temperature, and breathing rate). You will be
asked about drugs you have taken in the last 30 days. You will be asked to complete 2
questionnaires about your health and quality-of-life. These should take about 5 minutes to
complete. A traditional Chinese medicine (TCM) diagnosis will be completed by research
staff. This will include a check of your pulse, examination of your tongue, and answering
some general questions. The assessment will be conducted by a doctor, as well as by using a
heart-rate machine and taking a photograph of your tongue.

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to be in 1 of 2 groups. Participants in one group will receive
electro-stimulation at an active (responsive) acupuncture site on the bottom of the foot.
Participants in the other group will receive electro-stimulation at a inactive site on the
bottom of the foot (a placebo site).

Participants in both groups will have electro-stimulation on the feet. You will sit or lie
down in bed. The acupuncturist will wet the points with a cotton ball dipped in water and
attach the electrodes of the electro-stimulating instrument to the bottom of your feet. The
electrodes are little paddles that will be attached with tape. The acupuncturist will begin
slowly increasing the stimulation to a level you can withstand comfortably. This will last
about 30 minutes.

The stimulation will occur about 1-2 hours before your transarterial infusion (TAI)
chemotherapy on the first day, and then between 7-9 A.M. on the next 5 days.

After each electro-stimulation procedure, your vital signs will be measured, you will
complete quality-of-life questionnaires, and you will be asked about hiccups and diet
tolerance (how nausea has affected your ability to eat or how much you eat). After your
last electro-stimulation, you will also have a TCM diagnosis. This will include diagnosis
by a doctor as well as by using a heart-rate machine and taking a photograph of your tongue.
Blood (about 1 teaspoon) will also be drawn to check your liver function about 6 days after
the treatments.

You will be given the standard medicines if you experience uncontrolled nausea or vomiting
while on this study.

Your total participation on this study will last less than 2 weeks.

This is an investigational study. Up to 100 patients will take part in this study. All
will be enrolled at the Fudan University Cancer Hospital.