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

Primary Purpose

Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lorcaserin
Lorcaserin Hydrochloride
Questionnaire Administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anatomic Stage I Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment (lorcaserin)

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Measure the improvement in balance for patients with chronic CIPN
    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

    Improvement in patient-reported chemotherapy-induced peripheral neuropathy symptoms
    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

    Full Information

    First Posted
    August 5, 2019
    Last Updated
    January 14, 2021
    Sponsor
    Ohio State University Comprehensive Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04205071
    Brief Title
    Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer
    Official Title
    Pilot Trial of Acute Effect of Lorcaserin to Reduce Patient-Reported Symptoms of Taxane- and Oxaliplatin-Induced Peripheral Neuropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI decision
    Study Start Date
    November 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ohio State University Comprehensive Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Chemotherapy-Induced Peripheral Neuropathy, Digestive System Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment (lorcaserin)
    Arm Type
    Experimental
    Arm Description
    Patients receive lorcaserin PO on day 1. The starting dose of lorcaserin will be 10 mg.
    Intervention Type
    Drug
    Intervention Name(s)
    Lorcaserin
    Intervention Description
    Given PO
    Intervention Type
    Drug
    Intervention Name(s)
    Lorcaserin Hydrochloride
    Other Intervention Name(s)
    LORCASERIN HYDROCHLORIDE ANHYDROUS
    Intervention Description
    Given PO
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire Administration
    Intervention Description
    Ancillary studies
    Primary Outcome Measure Information:
    Title
    Measure the improvement in balance for patients with chronic CIPN
    Description
    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 .
    Time Frame
    Up to 4 weeks
    Secondary Outcome Measure Information:
    Title
    Improvement in patient-reported chemotherapy-induced peripheral neuropathy symptoms
    Description
    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
    Time Frame
    Baseline up to 4 weeks
    Other Pre-specified Outcome Measures:
    Title
    Nerve conduction test (NCT) result analysis
    Description
    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).
    Time Frame
    Baseline up to 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maryam B Lustberg, MD
    Organizational Affiliation
    Ohio State University Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    http://cancer.osu.edu
    Description
    The Jamesline

    Learn more about this trial

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

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