Ignite Creation Date:
2024-05-06 @ 2:04 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04205071
Status:
WITHDRAWN
Last Update Posted:
2021-01-19
First Post:
2019-08-05
Brief Title:
Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Pilot Trial of Acute Effect of Lorcaserin to Reduce Patient-Reported Symptoms of Taxane- and Oxaliplatin-Induced Peripheral Neuropathy
Status:
WITHDRAWN
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies how well lorcaserin works in treating chemotherapy-induced peripheral neuropathy in patients with stage I-IV gastrointestinal or breast cancer Chemotherapy-induced peripheral neuropathy is a nerve problem that causes pain numbness tingling swelling or muscle weakness in different parts of the body This condition can occur in patients who have received taxane chemotherapy drugs or the chemotherapy drug oxaliplatin Lorcaserin may improve chemotherapy-induced peripheral neuropathy by reducing pain preventing or relieving joint symptoms and improving balance
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate preliminary efficacy of lorcaserin to improve balance decrements in patients with chronic chemotherapy-induced peripheral neuropathy CIPN
SECONDARY OBJECTIVES
I To evaluate patient reported outcomes PROs after a one time dose of lorcaserin in patients with chronic CIPN
OUTLINE
Patients receive lorcaserin orally PO on day 1
After completion of study treatment patients are followed for 4 weeks
I To evaluate preliminary efficacy of lorcaserin to improve balance decrements in patients with chronic chemotherapy-induced peripheral neuropathy CIPN
SECONDARY OBJECTIVES
I To evaluate patient reported outcomes PROs after a one time dose of lorcaserin in patients with chronic CIPN
OUTLINE
Patients receive lorcaserin orally PO on day 1
After completion of study treatment patients are followed for 4 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA016058 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP30CA016058 |
| NCI-2019-03368 | REGISTRY | None | None |