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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04205071
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
1
Arm
14
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lorcaserin
  • Drug: Lorcaserin Hydrochloride
  • Other: Questionnaire Administration
 Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. To evaluate preliminary efficacy of lorcaserin to improve balance decrements in patients with chronic chemotherapy-induced peripheral neuropathy (CIPN).
SECONDARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Trial of Acute Effect of Lorcaserin to Reduce Patient-Reported Symptoms of Taxane- and Oxaliplatin-Induced Peripheral Neuropathy
Anticipated Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (lorcaserin)

Patients receive lorcaserin PO on day 1. The starting dose of lorcaserin will be 10 mg.

Drug: Lorcaserin
Given PO

Drug: Lorcaserin Hydrochloride
Given PO
Other Names:
  • LORCASERIN HYDROCHLORIDE ANHYDROUS

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Measure the improvement in balance for patients with chronic CIPN [Up to 4 weeks]

      Will be evaluated using a measure of postural control: root-mean-squared amplitude of center of pressure (COP) excursion for the medial-lateral axis of the body .

    Secondary Outcome Measures

    1. Improvement in patient-reported chemotherapy-induced peripheral neuropathy symptoms [Baseline up to 4 weeks]

      Evaluate using Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is an additional PRO. It is a validated instrument that has been used to evaluate pain symptoms and functional capacity in our target population.45

    Other Outcome Measures

    1. Nerve conduction test (NCT) result analysis [Baseline up to 4 weeks]

      The study will compare baseline variables of patients with abnormal NCT results to those with normal NCT results. Will present descriptive statistics and perform t-tests comparing the two groups with respect to demographics (age, BMI), RMSml, and patient-reported outcomes (CIPN 20, BPI-SF).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient with known diagnosis of gastrointestinal (GI) cancer or breast cancer stages I-IV

    • 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 beyond 24 months out from completion of oxaliplatin or paclitaxel

    • 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Maryam B Lustberg, MD, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Maryam Lustberg, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04205071
    Other Study ID Numbers:
    • OSU-19085
    • NCI-2019-03368
    • P30CA016058
    First Posted:
    Dec 19, 2019
    Last Update Posted:
    Jan 19, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Peripheral Nervous System Diseases

    Study Results

    No Results Posted as of Jan 19, 2021