Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

A Randomized Phase II Study Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin

A Randomized Phase II study Comparing Lorcaserin versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin

Study Overview

• Status: Unknown
• Conditions: Chemotherapy-Induced Peripheral Neuropathy
• Intervention / Treatment: Drug: Duloxetine 60 mg qd; Drug: Lorcaserin

Detailed Description

To examine lorcaserin a selective R-HT2c receptor antagonist approved by FDA as weight loss drug- for its ability to improve proprioceptive movements in patients with advanced colorectal cancer who developed neurotoxicity during oxaliplatin-based chemotherapy.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Cancer Treatment Centers of America - Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has a diagnosis of invasive colorectal cancer, locally advanced or advanced, requiring oxaliplatin-based chemotherapy for treatment.
• Subject has agreed to receive treatment at Cancer Treatment Centers of America, Southeastern Regional Medical Center.
• Subject is Male or Female
• Subject is 18 years of age or older.
• Subject is a patient who reports neurotoxicity symptom grade 2 or more according CTCAE criteria to his or her medical oncologist following one or more cycles of oxaliplatin-based chemotherapy treatment.
• Subject is a patient who is capable and accepting of completing study questionnaires at each data collection point.
• Subject has adequate English fluency for completion of data collection. The surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
• Subject must have the ability to understand and the willingness to sign a written informed consent
• Subject must be willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

• Subjects who have previously been exposed to neurotoxic agents including pyridoxine (>100 mg/day), colchicine, allopurinol, or phenytoin;
• Subjects with pre-existing comorbidities, such as: diabetes, uremia, significant peripheral vascular disease, HIV, or progressive or degenerative neurologic disorders (e.g., multiple sclerosis, B12 deficiency); cardiovascular valve disease, history of cardiovascular event,
• Subjects with a history of lumbosacral laminectomy or radiculopathy;
• Subjects who have been prescribed and taken gabapentin, pregabalin, or duloxetine currently or within the last 1 months)
• Subjects who have established or suspected family history of inherited neuropathy.
• Subjects unable to swallow indicated medication
• Subjects in general with a medical condition, laboratory finding, or physical exam finding that precludes participation
• Subject weight of ≥350 lbs.
• Subjects who currently use disallowed concomitant medications
• Subjects with any form of cardiac implants
• Subjects who report recent febrile illness that precludes or delays participation
• Subjects with pregnancy or lactation
• Subjects with known allergic reactions to components of the study product(s)
• Subjects receiving treatment with another investigational drug or other intervention
• Subjects with a history of or current tobacco or illegal substance use
• Subjects exhibiting significant psychiatric or cognitive impairment (dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control; Duloxetine 60 mg qd	Drug: Duloxetine 60 mg qd; 60 mg tablet Taken by mouth, Once Daily for 180 Days
EXPERIMENTAL: Intervention; Lorcaserin 10 mg bid	Drug: Lorcaserin; 10 mg tablet Taken by mouth Twice Daily for 180 Days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment with respect to duloxetine of the effect of lorcaserin on the Pain Numerical Rating Scale.	Duloxetine efficacy as Measured by Pain Score 0-10 Numerical Rating Scale. Subject will rate level of pain experienced from 0 (No Pain) to 10 (Worst Possible Pain) for each question on the Brief Pain Inventory Short Form. A rating of 5 would be Moderate Pain.	180 days
Assessment with respect to duloxetine of the effect of lorcaserin on the patient-reported quality of life.	Subject quality of life will be measured using the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group-Neurotoxocity (FACT/GOG-NTX) Questionnaire. For each statement, the subject will answer 0-5 with 0 being "Not at All" and 5 being "Very Much"	180 days
Assessment with respect to duloxetine of the effect of lorcaserin on the patient-reported quality of life.	Subject quality of life will also be measured using the MD Anderson Symptom Inventory (MDASI) Questionnaire, with CTCA addendum. For each statement, the subject will answer from 0-10, with 0 being "Not Present" and 10 being "As Bad as You Can Imagine)	180 days

Collaborators and Investigators

• Sponsor: Southeastern Regional Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2019
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (ACTUAL): January 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: SA2018005 LVD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No