Vomiting
Conditions
Keywords
Lymphoma, Aprepitant, Chemotherapy-induced nausea and vomiting (CINV), Autologous Hematopoietic Stem Cell Transplantation, Hematological Malignancies
Brief summary
The purpose of this study is to evaluate the efficacy and safety of additional aprepitant to standard antiemetic regimen in Autologous Hematopoietic Stem Cell Transplantation.
Detailed description
Chemotherapy-induced nausea and vomiting (CINV) is a serious complication of treatments of hematological malignancies. Although aprepitant has been shown to control CINV in highly emetogenic therapies for solid tumors, the antiemetic effect of aprepitant in hematological chemotherapies is still not clear. In this multi-central perspective randomized controlled study, the investigators are trying to evaluate the efficacy and safety of additional aprepitant to standard antiemetic regimen in Autologous Hematopoietic Stem Cell Transplantation.
Interventions
DRUGTropisetron
Tropisetron Hydrochloride Injection 5mg (Day 1-6)
DRUGDexamethasone
Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)
DRUGAprepitant
Aprepitant 125mg （Day1-2）, 80mg (Day 3-6)
Sponsors
Jun Zhu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and women \>/= 18 years, \<65 years * Patients with lymphoma receiving autologous hematopoietic stem cell transplantation for the first time * ECOG 0-2 * TBIL,AST and ALT \< 2.5-fold upper normal range * Female and male subjects of childbearing potential must agree to use a medically accepted method of adequate contraception. * Signed informed consent
Exclusion criteria
* Prior autologous/ allogeneic hematopoietic stem cell transplantation for lymphoma * Women who are pregnant or breast feeding. * Serious or uncontroled infection * Serious complications * Severe renal or hepatic disease * Severe mental or nervous system diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall complete response (no emesis and no rescue therapy) | During and post chemotherapy (0-120 h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to initial neutrophil engraftment | 30 days post-transplantation | Time to initial neutrophil engraftment is defined as 1st of 3 consecutive days of an ANC ≥0.5 × 10\^9/L |
| Time to initial platelet recovery | 30 days post-transplantation | Time to initial platelet recovery is defined as 1st of 3 consecutive platelet count measurements tested on different days with a count ≥20 × 10\^9/L with no platelet transfusion in the prior 7 days. |
| Quality of Life | During and post chemotherapy (0-120 h) | — |
| Safety and Tolerability assessed by possible side effects, and all AE will be reported during 30 days after the chemotherapy. | 30 days | — |
Outcome results
None listed