Symptoms and General Pathology

All Conditions

Nausea

Vomiting

Signs and Symptoms, Digestive

Antiemetics

Dermatologic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Central Nervous System Depressants

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Ondansetron

Granisetron

Prochlorperazine

Dolasetron

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Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Antipsychotic Agents

Dopamine

Dopamine Antagonists

Dopamine Agents

dolasetron mesylate

granisetron hydrochloride

ondansetron

prochlorperazine

quality-of-life assessment

Gary R. Morrow, PhD, MS

RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy.

PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.

OBJECTIVES:

* Compare the effectiveness of a 5 hydroxytryptamine 3 (5-HT3) receptor antagonist antiemetic vs prochlorperazine in controlling delayed nausea after chemotherapy in patients with chemotherapy-naive cancer.
* Compare the effectiveness of prochlorperazine administered on a preventive vs as needed basis in controlling delayed nausea after chemotherapy in these patients.
* Compare the quality of life of patients treated with a 5-HT3 receptor antagonist antiemetic vs prochlorperazine.
* Compare the quality of life of patients treated with prochlorperazine administered on a preventive vs as needed basis.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center.

Patients receive their scheduled chemotherapy regimen containing doxorubicin and their scheduled oral 5 hydroxytryptamine 3 receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) combined with dexamethasone on day 1.

Patients are then randomized to 1 of 3 antiemetic arms.

* Arm I: Patients receive oral prochlorperazine every 8 hours on days 2 and 3.
* Arm II: Patients receive oral ondansetron every 12 hours, oral granisetron every 12 hours, or oral dolasetron mesylate either once a day or every 12 hours on days 2 and 3.
* Arm III: Patients receive oral prochlorperazine as needed, up to 4 times per day, on days 2 and 3.

Quality of life is assessed at baseline and on day 4.

PROJECTED ACCRUAL: A total of 670 patients will be accrued for this study within 3 years.

Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer

Treatment of Delayed Nausea: What Works Best?

National Cancer Institute (NCI)

Gary Morrow

Director, University of Rochester NCORP Research Base

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer	NCT00020657	Nausea and Vomi... Unspecified Adu...	dolasetron mesy... granisetron hyd... ondansetron prochlorperazin... quality-of-life...	18 Years - 120 Years	University of Rochester
Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer	NCT00020657	Nausea and Vomi... Unspecified Adu...	dolasetron mesy... granisetron hyd... ondansetron prochlorperazin... quality-of-life...	18 Years - 120 Years	University of Rochester

Spots Global Cancer Trial Database for dolasetron mesylate