A study to find which drug (metoclopramide, thalidomide, prochlorperazine, or lorazepam) is best to treat vomiting due to chemotherapy in patients with cancer.

An open-label phase III randomized controlled trial comparing metoclopramide, thalidomide, prochlorperazine, and lorazepam for treating breakthrough chemotherapy-induced nausea and vomiting in patients receiving olanzapine as part of antiemetic prophylaxis for highly emetogenic chemotherapy. - Nil

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072429

Enrollment

200

Registered

2024-08-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Thalidomide: Tab. Thalidomide 50 mg per oral every 12 hours for 3 days. Intervention2: Lorazepam: Tab. Lorazepam 0.5 mg per oral every 6 hours for 3 days Intervention3: Prochlorperazine

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18 to 80 years and diagnosed with cancer. 2. Patients with solid malignancies receiving single-day HEC with 4 drug (OPDF) antiemetic prophylaxis. 3. Eastern Cooperative Oncology Group performance status of 0, 1, or 2. 4. Women enrolled in the trial need to have a negative pregnancy test within seven days of enrollment and continue to practice contraception during the study period. 5. Patients with breakthrough vomiting and/or ESAS nausea score more than 3 which occur within eight days of chemotherapy administration. 6. Written informed consent before enrollment.

Exclusion criteria

Exclusion criteria: 1. Pediatric patients (age less than 18 years). 2. Patients receiving lorazepam, thalidomide, prochlorperazine, or metoclopramide for other conditions. 3. Patients receiving multi-day chemotherapy in a chemotherapy block. 4. Patients with brain metastasis. 5. Patients receiving abdominal radiotherapy. 6. Patients in whom there are contraindications for the use of thalidomide, metoclopramide, prochlorperazine, or lorazepam like acute narrow-angle glaucoma, respiratory depression, sleep apnea, gastrointestinal hemorrhage, mechanical obstruction, or perforation. 7. History of allergy to any of the drugs used for anti-emetic prophylaxis. 8. Concomitant use of another benzodiazepine, opioids, or antipsychotics other than olanzapine during the protocol therapy. 9. Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous six months. 10. History of neurological disorders including seizures and stroke within the last 6 months. 11. History of gastric outlet or intestinal obstruction; severe electrolyte disorder; history of symptomatic thrombosis; history or suspected likelihood of using narcotic analgesics; inability to take or absorb oral medicine.

Design outcomes

Primary

Measure	Time frame
The number of patients with no episodes of vomiting after the use of rescue medication (CR) during 0 to 72 hours.Timepoint: 3 days	—

Secondary

Measure	Time frame
The number of patients with CR to nausea (score of 0 on the ESAS scale) during 0 to 72 hours after starting rescue antiemetic.Timepoint: 3 days;Comparison of toxicities among the four regimens.Timepoint: 5 days;Assessing patient-reported outcomes using the MD Anderson Symptom Inventory (MDASI).Timepoint: 5 days	—

Countries

India

Contacts

Public ContactVenkatraman Radhakrishnan

Cancer Institute (W.I.A)

venkymd@gmail.com9498082771

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026