Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Nausea

In brief

RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which combination of antiemetic drugs is more effective in preventing nausea caused by chemotherapy. PURPOSE: This randomized phase III trial is comparing different combinations of granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer.

Key facts

Study ID

NCT00475085

Run by

Joseph Roscoe

People needed

1021

Starts

2006-12-01

Last updated by the study team

2015-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of cancer and be chemotherapy naive.
• Must be scheduled to receive a chemotherapy treatment containing doxorubicin hydrochloride, epirubicin hydrochloride, cisplatin, carboplatin, or oxaliplatin (any dose or schedule) without concurrent radiotherapy or interferon treatment
• Chemotherapy may be for adjuvant, neoadjuvant, curative or palliative intent.
• Dose-dense regimens (e.g. chemotherapy with doxorubicin or epirubicin given every two weeks)are allowed.
• For the purposes of this study, Day 1 of chemotherapy will be defined as the day of administration of cisplatin, carboplatin, oxaliplatin, doxorubicin or epirubicin.
• Regimens with multiple-day doses of doxorubicin, epirubicin, cisplatin, carboplatin, oxaliplatin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin are not allowed. Chemotherapy agents, other than those listed above, may be given orally, intravenously, or by continuous infusion on one or multiple days.
• Able to understand English

You may not qualify if…

• No symptomatic brain metastases
• No concurrent or impending bowel obstruction
• Regimens containing liposomal doxorubicin or cisplatin are not allowed.
• No concurrent pimozide, terfenadine, astemizole, or cisapride
• No concurrent doxorubicin hydrochloride liposome or cisplatin
• No concurrent multiple-day doses of dacarbazine, altretamine, nitrosoureas, streptozocin, cisplatin, carboplatin, or oxaliplatin

Where it is running

• MBCCOP - Gulf Coast — Mobile, Alabama, United States
• CCOP - Central Illinois — Decatur, Illinois, United States
• CCOP - Wichita — Wichita, Kansas, United States
• CCOP - Grand Rapids — Grand Rapids, Michigan, United States
• CCOP - Kalamazoo — Kalamazoo, Michigan, United States
• CCOP - Metro-Minnesota — Saint Louis Park, Minnesota, United States
• CCOP - Kansas City — Kansas City, Missouri, United States
• CCOP - Nevada Cancer Research Foundation — Las Vegas, Nevada, United States
• CCOP - Hematology-Oncology Associates of Central New York — East Syracuse, New York, United States
• CCOP - North Shore University Hospital — Manhassett, New York, United States
• CCOP - Southeast Cancer Control Consortium — Goldsboro, North Carolina, United States
• CCOP - Columbus — Columbus, Ohio, United States
• CCOP - Dayton — Dayton, Ohio, United States
• CCOP - Greenville — Greenville, South Carolina, United States
• CCOP - Northwest — Tacoma, Washington, United States
• CCOP - Marshfield Clinic Research Foundation — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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