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

Southeastern Regional Medical Center

Status and phase: Unknown; Phase 2

Conditions: Chemotherapy-Induced Peripheral Neuropathy

Treatments: Drug: Lorcaserin; Drug: Duloxetine 60 mg qd

Study type: Interventional

Funder types: Other

Identifiers

NCT03812523

SA2018005 LVD

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Control

Active Comparator group

Description:

Duloxetine 60 mg qd

Treatment:

Drug: Duloxetine 60 mg qd

Intervention

Experimental group

Description:

Lorcaserin 10 mg bid

Treatment:

Drug: Lorcaserin