Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation

The Catholic University of Korea

Status and phase: Unknown; Phase 2

Conditions: Hematologic Malignancies

Treatments: Drug: ramosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT01788605

CBMTC-supp001

Details and patient eligibility

About

1. The purpose of this study is to determine the efficacy of ramosetron for the prevention of emesis and the control of nausea and vomiting despite of the prophylactic antiemetic treatment during hematopoietic stem cell transplantation
2. The study hypothesis is that ramosetron is effective for the prevention of emesis and control of emesis and/or vomiting that develop after the prophylactic antiemetic therapy in the setting of hematopoietic stem cell transplantation

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients undergoing hematopoietic stem cell transplantation conditioned with highly or moderately emetogenic drugs or total body irradiation (TBI) for hematologic malignancies
2. aged over 18 yrs
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
4. patients who are able to take oral medications
5. patients who get well-informed and sign the consent

Exclusion criteria

1. Patients complicating

   • severe hypertension (systolic blood pressure > 210 mmHg or diastolic blood pressure > 120 mmHg)
   • significant heart disease such as congestive heart failure
   • renal insufficiency (serum Cr >= 3.0 mg/dL)
   • liver disease (Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3 upper normal limit; alkaline phosphatase (ALP) > 2 upper normal limit)

2. Patients complicated by conditions such as gastrointestinal obstruction or active peptic ulcer causing emesis

3. Patients with brain tumor, brain metastasis and epilepsy

4. Patients with the history of extrapyramidal symptom

5. Patients with the history of allergy to serotonin antagonists

6. pregnant or lactating women

7. Patients with drug abuse or psychiatric illness, or patients who are not capable of the normal communications

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

ramosetron

Experimental group

Treatment:

Drug: ramosetron