Clinical trial NCT03812523: Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Official title: A Randomized Phase II Study Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chemotherapy-Induced Peripheral Neuropathy
Lead sponsor: Southeastern Regional Medical Center
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Assessment with respect to duloxetine of the effect of lorcaserin on the Pain Numerical Rating Scale.
timeFrame: 180 days
measure: Assessment with respect to duloxetine of the effect of lorcaserin on the patient-reported quality of life.
timeFrame: 180 days
measure: Assessment with respect to duloxetine of the effect of lorcaserin on the patient-reported quality of life.
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Newnan
country: United States
facility: Cancer Treatment Centers of America - Atlanta
state: Georgia
Study officials:
References: