A Randomized Phase II study Comparing Lorcaserin versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
60 mg tablet Taken by mouth, Once Daily for 180 Days
10 mg tablet Taken by mouth Twice Daily for 180 Days
Cancer Treatment Centers of America - Atlanta
Newnan, Georgia, United States
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.
Time frame: 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"
Time frame: 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)
Time frame: 180 days
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