Clinical trial NCT04150614: BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Official title: BMT-08: A Comparative Effectiveness Study of the Efficacy and Safety of Transdermal Granisetron to Ondansetron in the Prevention of Nausea and Vomiting in Patients Undergoing Preparative Chemotherapy and Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chemotherapy-induced Nausea and Vomiting
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1 to either Arm 1 transdermal granisetron OR Arm 2 intravenous ondansetron
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients undergoing either an autologous or allogeneic hematopoietic stem cell transplant (HSCT) and receiving preparative chemotherapy experience a considerable amount of chemotherapy-induced nausea and vomiting (CINV). Current strategies at reducing CINV in this patient population are suboptimal due to lack of efficacy and supportive evidence, potential for increased adverse events, and drug-drug and drug-disease contraindications.

Detailed description: Patients undergoing either an autologous or allogeneic hematopoietic stem cell transplant (HSCT) and receiving preparative chemotherapy experience a considerable amount of chemotherapy-induced nausea and vomiting (CINV). Current strategies at reducing CINV in this patient population are suboptimal due to lack of efficacy and supportive evidence, potential for increased adverse events, and drug-drug and drug-disease contraindications. This study will be an open-label, prospective trial randomizing patients at a 1:1 ratio, to either one of two 5-hydroxytrytamine 3 (5-HT3) antagonists, transdermal granisetron or intravenous (i.v.) ondansetron, in combination with other standard, routinely administered anti-emetic drugs (dexamethasone). Rescue antiemetics will be administered at any time during the study period for vomiting or severe nausea at the request of the patients or as recommended by the attending physicians. For the granisetron treatment arm, patients will be educated and instructed to self-administer a single transdermal granisetron patch one-two days (approximately 24-48 hours) prior to start of the preparative regimen. An additional dose of transdermal granisetron will be administered 7 days after the initial granisetron dose. For the ondansetron treatment arm, patients will receive the standard dose and schedule of intravenous ondansetron that is routinely administered for each respective preparative regimen. Use of rescue medications will be assessed daily during chemotherapy, and for 7 days after the last chemotherapy drug administration (delayed phase). Nausea, vomiting, and treatment-related side effects will be documented and followed during this same time period. A quality of life questionnaire (MDASI-BMT) will be administered at Day + 7 (7 days after day of infusion). All other aspects of patient care (i.e., chemotherapy administration, supportive care, etc.) and laboratory monitoring will adhere to the routine standard of care operating procedures for stem cell transplant patients.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years at time of enrollment receiving either a preparative regimen and either an autologous or allogeneic stem cell transplant.
* No vomiting ≤ 24 hours prior to registration
* No treatment with an antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for ≤ 30 days' prior registration or planned during protocol therapy. No patients will be removed from these treatments for study enrollment purposes.
* No chronic phenothiazine administration as an antipsychotic agent (patients may receive prochlorperazine and other phenothiazines as rescue antiemetic therapy). No patients will be removed from these treatments for study enrollment purposes.
* No known hypersensitivity to granisetron

Exclusion Criteria:

* Concurrent use of amifostine
* Known hypersensitivity to granisetron patch or ondansetron
* Patients with a history of long QT syndrome or Torsade de Pointes

Primary outcomes:
measure: Efficacy/Safety of Transdermal Granisetron for Prevention of CINV
timeFrame: 2 years
Secondary outcomes:
measure: Efficacy/Safety of Ondansetron for Prevention of CINV
timeFrame: 2 years
measure: Efficacy/Safety of Ondansetron and Transdermal Granisetron for Prevention of CINV
timeFrame: 2 years
measure: Efficacy/Safety of Ondansetron and Transdermal Granisetron for Prevention of CINV
timeFrame: 2 years
measure: Efficacy/Safety of Ondansetron and Transdermal Granisetron for Prevention of CINV
timeFrame: 2 years
measure: Efficacy/Safety of Ondansetron and Transdermal Granisetron for Prevention of CINV
timeFrame: 2 years
measure: Efficacy/Safety of Ondansetron and Transdermal Granisetron for Prevention of CINV
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Cancer Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Karen Sweiss, PharmD
role: PRINCIPAL_INVESTIGATOR
References: