Name of the Trial
Phase III Randomized Study of Different Combinations of Granisetron Hydrochloride, Dexamethasone, Prochlorperazine, Aprepitant, and Palonosetron Hydrochloride in Preventing Delayed Nausea in Women Undergoing Chemotherapy for Chemotherapy-Naive Breast Cancer (URCC-04-02). See the protocol summary at http://cancer.gov/clinicaltrials/URCC-04-02.

Principal Investigator
Dr. Joseph Roscoe, University of Rochester Cancer Center

Why This Trial Is Important
Nausea is a common side effect of cancer chemotherapy. Severe nausea may keep patients from consuming enough food and liquids to maintain their energy and prevent dehydration, and it can lead to disruptions in cancer treatment.

A number of drugs are available to treat and prevent chemotherapy-induced nausea, but it is unclear which drug or combination of drugs is most effective for patients experiencing delayed nausea. Delayed nausea is nausea that occurs more than 24 hours after chemotherapy is administered. It is often more severe than the acute nausea that may occur during chemotherapy, and it may have a different underlying cause.

In this trial, different combinations of drugs will be tested to see which is most effective in preventing delayed nausea in women undergoing chemotherapy for breast cancer.

"Because of the types of drugs they receive, as many as 70 percent of breast cancer patients undergoing chemotherapy experience nausea," said Dr. Roscoe, "so we're very interested in finding more effective ways of preventing and treating nausea in this population.

"This study is part of a line of research our cooperative group has been conducting into nausea and vomiting," he added, "and, although vomiting is becoming less of a problem thanks to advances in antiemetic drugs, delayed nausea continues to be a very prevalent side effect for women with breast cancer who undergo chemotherapy."

Who Can Join This Trial
Researchers will enroll 890 women diagnosed with breast cancer that has not yet been treated with chemotherapy. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/URCC-04-02.

Study Site and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study contacts at http://cancer.gov/clinicaltrials/URCC-04-02 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.