Clinical trial NCT01788605: Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation
Official title: Prospective, Single-arm Phase 2 Trial to Evaluate Efficacy and Safety of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation for Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hematologic Malignancies
Keywords: hematologic malignancies
hematopoietic stem cell transplantation
ramosetron
emesis
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: efficacy of ramosetron in terms of complete response (no emesis, no rescue therapy) during the conditioning regimen and within 3 or 6 days after the end of the conditioning regimen
timeFrame: within 1 week after the end of conditioning regimen
Secondary outcomes:
measure: the efficacy of second dose of ramosetron for the treatment of breakthrough emesis
timeFrame: within 1 week after the end of conditioning regimen
Other outcomes:
measure: the number of vomiting episodes
timeFrame: within 1 week after the end of conditioning regimen
measure: grade of nausea and need for rescue therapy
timeFrame: within 1 week after the end of conditioning regimen
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic Blood & Marrow Transplantation Center, Seoul St Mary's Hospital, the Catholic University of Korea
Study officials:
References: