Phase 3
N=1,021
Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial
Nausea
Bottom Line
View on ClinicalTrials.gov: NCT00475085 ↗Enrolled (actual)
1,021
Serious AEs
—
Results posted
Nov 2013
Primary outcome: Primary: Home Record: Severity of Delayed Nausea — 1.88; 1.65; 1.87; 1.68 units on a scale — p=0.718
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- aprepitant (Drug); dexamethasone (Drug); granisetron hydrochloride (Drug); palonosetron hydrochloride (Drug); prochlorperazine (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Joseph Roscoe
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Home Record: Severity of Delayed Nausea |
1.88; 1.65; 1.87; 1.68 | 0.718 |
Summary
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.
Eligibility Criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00475085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.