Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer
NCT ID: NCT04205071
Last Updated: 2021-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2020-11-01
2021-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (lorcaserin)
Patients receive lorcaserin PO on day 1. The starting dose of lorcaserin will be 10 mg.
Lorcaserin
Given PO
Lorcaserin Hydrochloride
Given PO
Questionnaire Administration
Ancillary studies
Interventions
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Lorcaserin
Given PO
Lorcaserin Hydrochloride
Given PO
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior exposure to paclitaxel or oxaliplatin within last 24 months
* Have symptomatic CIPN confirmed by self-report, as demonstrated by PRO measure, CIPN-20
* If a female subject is with child bearing potential, she must have a negative pregnancy test at screening
* Female subjects of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 3 months after completion of study treatment administration. Adequate contraception includes methods such as oral contraceptives, double barrier method (condom plus spermicide or diaphragm), or abstaining from sexual intercourse
* Be willing and able to understand and sign the written informed consent document
Exclusion Criteria
* Is asymptomatic for CIPN
* Is currently pregnant or breast feeding as there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lorcaserin
* Has any other medical or psychiatric condition that in the opinion of the investigator would make the study therapy unsafe for the patient
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Maryam Lustberg
Principal Investigator
Principal Investigators
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Maryam B Lustberg, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Related Links
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The Jamesline
Other Identifiers
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NCI-2019-03368
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-19085
Identifier Type: -
Identifier Source: org_study_id
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