Metoclopramide to prevent chemotherapy induced nausea and vomiting: a randomized controlled trial
- Conditions
- Health Condition 1: C189- Malignant neoplasm of colon, unspecifiedHealth Condition 2: C159- Malignant neoplasm of esophagus, unspecifiedHealth Condition 3: C19- Malignant neoplasm of rectosigmoidjunctionHealth Condition 4: C20- Malignant neoplasm of rectumHealth Condition 5: C169- Malignant neoplasm of stomach, unspecified
- Registration Number
- CTRI/2023/08/056828
- Lead Sponsor
- no sponsor
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Eastern Cooperative Oncology Group performance status <3
Patients who are scheduled to receive Oxaliplatin based chemotherapy for treatment of a histologically confirmed solid malignancy.
Adequate bone marrow, hepatic and renal functions.
Patients receiving radiotherapy within 2 weeks before initiation of chemotherapy or between days 1 and 8 after the administration of chemotherapy
Receipt of medication with antiemetic effect up to 48 hours before chemotherapy
Vomiting, retching, or nausea up to 48 hours before chemotherapy
Conditions such as intestinal obstruction, active peptic ulcer,hypercalcemia, uncontrolled diabetes mellitus(fasting blood sugar >125,or Postprandial Blood sugar >199), pheochromocytoma,brain or leptomeningeal metastases, parkinsonism,epilepsy, or psychiatric disorders.
Concurrent use of corticosteroids
Pregnant or nursing women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoint is total control (TC; no emetic episodes, no nausea as assessed by Baxter Animated Retching Faces(BARF) Nausea Likert scale, no use of rescue medications. <br/ ><br>Timepoint: Day 8 of chemotherapy cycle <br/ ><br>
- Secondary Outcome Measures
Name Time Method Secondary objectives include antiemetics-associated side effects as assessed by the Dexamethasone Symptom Questionnaire (DSQ) & Abnormal Involuntary Movement Scale(AIMS) <br/ ><br>Timepoint: Day 8 of chemotherapy cycle;Secondary objectives include impact of Chemotherapy induced nausea & vomiting on quality of life as assessed by the Functional Living Index-Emesis QuestionnaireTimepoint: Day 8 of chemotherapy cycle