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Trial record 7 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

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

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ClinicalTrials.gov Identifier: NCT03812523
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Southeastern Regional Medical Center

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

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Peripheral Neuropathy Drug: Duloxetine 60 mg qd Drug: Lorcaserin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a two-arm randomized controlled clinical trial in cancer patients receiving oxaliplatin treatment reporting neurotoxicity Grade 2 or higher by CTCAE guidelines to a member of their medical team. Enrollment goal is 50 patients. (25 evaluable patients per arm)
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Coded Bottles
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Assessment with respect to duloxetine of the effect of lorcaserin on the Pain Numerical Rating Scale. [ Time Frame: 180 days ]
    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.

  2. Assessment with respect to duloxetine of the effect of lorcaserin on the patient-reported quality of life. [ Time Frame: 180 days ]
    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"

  3. Assessment with respect to duloxetine of the effect of lorcaserin on the patient-reported quality of life. [ Time Frame: 180 days ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812523


Contacts
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Contact: Nathan Neufeld, DO 770-400-6035 nathan.neufeld@ctca-hope.com
Contact: Ricardo Alvarez, MD 770-400-6633 ricardo.alvarez@ctca-hope.com

Locations
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United States, Georgia
Cancer Treatment Centers of America - Atlanta Not yet recruiting
Newnan, Georgia, United States, 30265
Contact: Karen Rados    770-400-6629    karen.rados@ctca-hope.com   
Principal Investigator: Nathan Neufeld, DO         
Sponsors and Collaborators
Southeastern Regional Medical Center

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Responsible Party: Southeastern Regional Medical Center
ClinicalTrials.gov Identifier: NCT03812523     History of Changes
Other Study ID Numbers: SA2018005 LVD
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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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
Additional relevant MeSH terms:
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Neuromuscular Diseases
Serotonin and Noradrenaline Reuptake Inhibitors
Peripheral Nervous System Diseases
Nervous System Diseases
Duloxetine Hydrochloride
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents