Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT04205071

Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer

Pilot Trial of Acute Effect of Lorcaserin to Reduce Patient-Reported Symptoms of Taxane- and Oxaliplatin-Induced Peripheral Neuropathy

Status
Withdrawn
Phase
Phase 1
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Ohio State University Comprehensive Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGLorcaserinGiven PO
DRUGLorcaserin HydrochlorideGiven PO
OTHERQuestionnaire AdministrationAncillary studies

Timeline

Start date
2020-11-01
Primary completion
2021-12-31
Completion
2021-12-31
First posted
2019-12-19
Last updated
2021-01-19

Regulatory

Source: ClinicalTrials.gov record NCT04205071. Inclusion in this directory is not an endorsement.