Pediatric Cancer Clinical Trial
Official title:
Efficacy, Safety and Feasibility of Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients With Solid Tumors Receiving Moderately and Highly Emetogenic Chemotherapy
The purpose is to evaluate the effectiveness and safety of fosaprepitant plus ondansetron with dexamethasone or placebo plus ondansetron with dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) with MEC/HE multi-day chemotherapy in children with solid tumors.
Participants will randomly assigned 1:1 to receive double-blind study drug ( fosaprepitant plus ondansetron with dexamethasone OR placebo to fosaprepitant plus ondansetron with dexamethasone). Fosaprepitant or placebo to fosaprepitant were supplied and administered in a blinded manner. Experimental: Participants received a single dose of fosaprepitant (age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron (weight based) IV with dexamethasone (weight based) iv/po prior to chemotherapy and up to 72 hours after chemotherapy. Placebo Comparator: Participants received a single dose of matched placebo for fosaprepitant administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron (weight based) IV with dexamethasone (weight based) iv/po prior to chemotherapy and up to 72 hours after chemotherapy. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
| Not yet recruiting |
NCT06335745 -
PediCARE Health Equity Intervention in High-Risk Neuroblastoma
|
N/A | |
| Withdrawn |
NCT04719416 -
Relaxation Therapy in Pediatric Oncology
|
N/A | |
| Completed |
NCT01645436 -
Physical Activity in Pediatric Cancer (PAPEC)
|
N/A | |
| Completed |
NCT04409301 -
Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation
|
N/A | |
| Completed |
NCT04914702 -
Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
|
||
| Recruiting |
NCT05425043 -
Granulocyte Transfusions After Umbilical Cord Blood Transplant
|
N/A | |
| Recruiting |
NCT05071859 -
Genetic Overlap Between Anomalies and Cancer in Kids in the Children's Oncology Group: The COG GOBACK Study
|
||
| Recruiting |
NCT03241251 -
Screening for Psychosocial Risk in Flemish Families of a Child With Cancer
|
||
| Recruiting |
NCT05384288 -
Response to Influenza Vaccination in Pediatric Oncology Patients
|
||
| Completed |
NCT04586491 -
The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients
|
N/A | |
| Recruiting |
NCT05569512 -
Uproleselan With Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for AML
|
Phase 1/Phase 2 | |
| Enrolling by invitation |
NCT05294380 -
Determination of Sarcopenia Risk and Related Factors in Pediatric Oncological Patients
|
||
| Completed |
NCT02665819 -
Long Term Support for Pediatric Cancer Adult Survivors in Rhône-Alpes : Evaluation of Women Fertility.
|
N/A | |
| Completed |
NCT02675166 -
Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes
|
||
| Not yet recruiting |
NCT05454163 -
Post-radiotherapy Rhinosinusitis in Children
|
||
| Terminated |
NCT02536183 -
A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT01828502 -
Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
|
Phase 2 | |
| Completed |
NCT02032121 -
Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors
|
N/A | |
| Completed |
NCT03964259 -
Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
|
Phase 1 |