Chemotherapy-Induced Peripheral NeuropathyPhase 2NCT03812523
Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
A Phase 2 study testing Duloxetine 60 mg qd and Lorcaserin in people with Chemotherapy-Induced Peripheral Neuropathy, run by Southeastern Regional Medical Center at 1 site in United States.
Trial summary
A Randomized Phase II study Comparing Lorcaserin versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy
- What is being tested?
- Duloxetine 60 mg qd and Lorcaserin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2019to Oct 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Cancer Treatment Centers of America - Atlanta
Newnan, Georgia, 30265
Karen Rados, 770-400-6629, karen.rados@ctca-hope.com
Nathan Neufeld, DO
About this study
Official title: A Randomized Phase II Study Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin
A Randomized Phase II study Comparing Lorcaserin versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin
Read the 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.
- Being tested
- Duloxetine 60 mg qd, Lorcaserin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine 60 mg qdDrug
60 mg tablet Taken by mouth, Once Daily for 180 Days
LorcaserinDrug
10 mg tablet Taken by mouth Twice Daily for 180 Days
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Duloxetine 60 mg qd Receives: Drug: Duloxetine 60 mg qd |
| Intervention | Experimental | Lorcaserin 10 mg bid Receives: Drug: Lorcaserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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"
Measured: 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)
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study startJun 2019 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeastern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812523
- Sponsor's protocol ID
- SA2018005 LVD
- Status last verified
- Apr 2019
- First submitted
- 4 Jan 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin
- ClinicalTrials.gov ID
- NCT03812523
- Acronym / sponsor ID
- SA2018005 LVD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Southeastern Regional Medical CenterUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Duloxetine 60 mg qdDuloxetine 60 mg qd |
| Intervention | Experimental | Drug: LorcaserinLorcaserin 10 mg bid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duloxetine 60 mg qd60 mg tablet Taken by mouth, Once Daily for 180 Days | Drug | Control |
| Lorcaserin10 mg tablet Taken by mouth Twice Daily for 180 Days | Drug | Intervention |
Primary outcome
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.
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"
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duloxetine 60 mg qd and Lorcaserin in people with Chemotherapy-Induced Peripheral Neuropathy, run by Southeastern Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathan Neufeld, DO (770-400-6035, nathan.neufeld@ctca-hope.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment with respect to duloxetine of the effect of lorcaserin on the Pain Numerical Rating Scale. (time frame: 180 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.