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
1 other identifier
interventional
50
1 country
1
Brief Summary
A Randomized Phase II study Comparing Lorcaserin versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2019
CompletedFirst Posted
Study publicly available on registry
January 23, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedApril 4, 2019
April 1, 2019
1.7 years
January 4, 2019
April 2, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Control
ACTIVE COMPARATORDuloxetine 60 mg qd
Intervention
EXPERIMENTALLorcaserin 10 mg bid
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Treatment Centers of America - Atlanta
Newnan, Georgia, 30265, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Coded Bottles
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2019
First Posted
January 23, 2019
Study Start
June 1, 2019
Primary Completion
February 1, 2021
Study Completion
October 1, 2021
Last Updated
April 4, 2019
Record last verified: 2019-04