Metoclopramide to prevent chemotherapy induced nausea and vomiting: a randomized controlled trial

Metoclopramide or dexamethasone, for prevention of delayed chemotherapy- induced nausea and vomiting after oxaliplatin based chemotherapy-a randomized controlled noninferiority trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056828

Enrollment

140

Registered

2023-08-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C189- Malignant neoplasm of colon, unspecified Health Condition 2: C159- Malignant neoplasm of esophagus, unspecified Health Condition 3: C19- Malignant neoplasm of rectosigmoidjunction Health Condition 4: C20- Malignant neoplasm of rectum Health Condition 5: C169- Malignant neoplasm of stomach, unspecified

Interventions

Intervention1: Metoclopramide: Patients in this arm will receive Injection Ondansetron 8 mg intravenously and Injection Dexamethasone 12 mg intravenously on day 1 with Tablet Metoclopramide 10 mg per

Eligibility

Inclusion criteria

Inclusion criteria: Eastern Cooperative Oncology Group performance status Patients who are scheduled to receive Oxaliplatin based chemotherapy for treatment of a histologically confirmed solid malignancy. Adequate bone marrow, hepatic and renal functions.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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. Timepoint: Day 8 of chemotherapy cycle	—

Secondary

Measure	Time frame
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;Secondary objectives include antiemetics-associated side effects as assessed by the Dexamethasone Symptom Questionnaire (DSQ) & Abnormal Involuntary Movement Scale(AIMS) Timepoint: Day 8 of chemotherapy cycle	—

Measure

Time frame

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;Secondary objectives include antiemetics-associated side effects as assessed by the Dexamethasone Symptom Questionnaire (DSQ) & Abnormal Involuntary Movement Scale(AIMS) Timepoint: Day 8 of chemotherapy cycle

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Countries

India

Contacts

Public ContactGayathri R Nair

Madras Medical College

sgd8gangadaran@gmail.com9841096885

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026