Cancer
Conditions
Keywords
chemotherapy induced nausea and vomiting, metoclopramide
Brief summary
The objective of this study is to assess the efficacy and tolerability of metoclopramide added to standard antiemetic regimen for prophylaxis of cisplatin-induced emesis.
Detailed description
Ondansetron plus dexamethasone are standard emetic prophylactic agents for highly emetogenic chemotherapy. Metoclopramide is a dopamine antagonist, which may enhance efficacy of ondansetron and dexamethasone.
Interventions
DRUGmetoclopramide
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg oral four times a day on day 2-5
DRUGplacebo
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus placebo 20 mg oral four times a day on day 2-5
Sponsors
Siriraj Hospital
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* schedule to receive first cycle of cisplatin \> 50 mg/m\^2 * pathologically or histologically confirmed solid cancer * more than 18 years old * creatinine clearance more than 50 ml/min * aminotransferase less than 2 times of upper normal limit
Exclusion criteria
* pregnant woman * patients with episode of vomiting within 24 hours prior to chemotherapy session * gut obstruction * brain metastasis * abdominal or pelvic irradiation * no history of allergy to study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Had Complete Response | 5 days after receiving chemotherapy | number of patients who experience no emesis and need no rescue treatment in 5-day period |
Secondary
| Measure | Time frame |
|---|---|
| Toxicities and Severity of Nausea and Vomiting | 5 days after receiving chemotherapy |
Countries
Thailand
Participant flow
Recruitment details
Recruitment period from April 2009-June 2010.
Pre-assignment details
All recruited patients were participate enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Metoclopramide ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5 | 83 |
| Placebo ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5 | 79 |
| Total | 162 |
Baseline characteristics
| Characteristic | Metoclopramide | Placebo | Total |
|---|---|---|---|
| Age, Customized >= 50 years | 42 participants | 41 participants | 83 participants |
| Age, Customized Between 18 and 50 years | 41 participants | 38 participants | 79 participants |
| Region of Enrollment Thailand | 83 participants | 79 participants | 162 participants |
| Sex: Female, Male Female | 23 Participants | 21 Participants | 44 Participants |
| Sex: Female, Male Male | 60 Participants | 58 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 67 / 83 | 62 / 79 |
| serious Total, serious adverse events | 0 / 83 | 0 / 79 |
Outcome results
Primary
Number of Patients Who Had Complete Response
number of patients who experience no emesis and need no rescue treatment in 5-day period
Time frame: 5 days after receiving chemotherapy
Population: intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metoclopramide | Number of Patients Who Had Complete Response | 50 participants |
| Placebo | Number of Patients Who Had Complete Response | 42 participants |
Comparison: the study had 80 percent power to detect an absolute difference of 20 percent in complete response (70% for metoclopramide group vs 50% for control group)p-value: 0.41Chi-squared
Secondary
Toxicities and Severity of Nausea and Vomiting
Time frame: 5 days after receiving chemotherapy