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Memantine XR and Pregabalin for Chemotherapy-Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT03709888
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Santosh Kesari, John Wayne Cancer Institute

Brief Summary:
Study is designed to assess the efficacy and safety of memantine XR and pregabalin in reducing neuropathic pain in patients with chemotherapy-induced peripheral neuropathy (CIPN) caused by prior treatment with any chemotherapy as measured by the Brief Pain Inventory- Short Form (BPI-SF). It will also determine the influence of these drugs on peripheral neuropathy-related functional status and quality of life (QOL) as measured by the EORTC QLQ-C30.

Condition or disease Intervention/treatment
Chemotherapy-induced Peripheral Neuropathy Drug: Memantine XR-pregabalin combination therapy

Detailed Description:
Using an observational, case-only, prospective design, potential subjects will be identified from patients with chemotherapy induced peripheral neuropathy (CIPN) that are planning to be treated with memantine XR-pregabalin combination therapy. The primary objective is to assess the efficacy of memantine XR and pregabalin in reducing neuropathic pain as measured by the Brief Pain Inventory- Short Form (BPI-SF). Patients who agree to participate will be asked to complete study questionnaires prior to the start of their CIPN treatment and once per week for six weeks during their treatment. After this period, patients will be contacted once per month for three months to assess interval medical history, concomitant medications, and adverse events.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study Efficacy and Safety of Memantine XR (Extended Release) and Pregabalin Combination Therapy in Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : December 18, 2019
Estimated Study Completion Date : December 18, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observation Group
Subjects will be identified from patients with chemotherapy induced peripheral neuropathy (CIPN) that are planning to be treated with memantine XR-pregabalin combination therapy.Patients who agree to participate will be asked to complete study questionnaires prior to the start of their CIPN treatment and once per week for six weeks during their treatment.
Drug: Memantine XR-pregabalin combination therapy
Pregabalin and memantine XR work in different pathways and are approved by the U.S. Food and Drug Administration for various indications. Both medications have an established safety profile and have demonstrated improvement on neuropathy-related symptoms.
Other Name: Namenda XR-Lyrica




Primary Outcome Measures :
  1. Change in average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF) [ Time Frame: 6 weeks ]
    Absolute change in the average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF) from baseline to the end of 6 weeks measured by item # 5 of Brief Pain Inventory Score (BPI-SF). The BPI assesses pain at its "worst," "least," "average," and "now" (current pain). In clinical trials, the items "worst" and "average" have each been used singly to represent pain severity. A composite of the four pain items (a mean severity score) is sometimes presented as supplemental information.


Secondary Outcome Measures :
  1. Change in quality of life (QOL) as measured by European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: 6 weeks ]
    Absolute change in the QoL measured by European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) after 6 weeks of treatment compared to baseline. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  2. Change in the intensity of mechanical allodynia measured using qualitative sensory testing [ Time Frame: 6 weeks ]
    Absolute change in mechanical allodynia intensity after 6 weeks of treatment compared to baseline. Testing is done by touching the sensitive (neuropathic) area with a foam brush 3 times in 5 secs and asking the patient about their pain score before and after the procedure.

  3. Change in neuropathic symptoms as measured by Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: 6 weeks ]
    Absolute change in neuropathic symptoms measured by Neuropathic Pain Symptom Inventory (NPSI) scores after 6 weeks of treatment compared to baseline. A total intensity score can be calculated as the sum of the scores of the 10 descriptors ranging from 0 to 100. Five subscores corresponding to the mean scores of the items belonging to each of the five dimensions ranging from 0 to 10. ) is "no pain" and 10 is "the most intense pain imaginable".

  4. Change in reported sleep interference as measured by item # 9 of Brief Pain Inventory- Short Form (BPI-SF) [ Time Frame: 6 weeks ]
    Absolute change in sleep interference measured by item # 9 of Brief Pain Inventory Score (BPI-SF) after 6 weeks of treatment from baseline. Score for question 9F for sleep ranges from 0 "does not interfere" to 10 "completely interferes".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chemotherapy induced peripheral neuropathy (CIPN) that are planning to be treated with memantine XR-pregabalin combination therapy
Criteria

Inclusion Criteria:

Ability to understand and the willingness to sign a written informed consent. History of any type of cancer treated with chemotherapy.

Chemotherapy induced peripheral neuropathy (CIPN) due to:

  • Cisplatin, carboplatin, and oxaliplatin
  • Taxanes- paclitaxel, docetaxel, and cabazitaxel
  • Thalidomide, lenalidomide, and pomalidomide
  • Plant alkaloids, such as vinblastine, vincristine, vinorelbine, and etoposide
  • Epothilones, such as ixabepilone
  • Bortezomib, carfilzomib
  • Eribulin Planning to receive treatment for CIPN with memantine XR and pregabalin. Average daily neuropathic pain intensity > 4 measured by item #5 of BPI-SF (Average daily pain at baseline is the average of pain scores over the last 7 days before enrolling patients in to the study).

CIPN > grade 1 as measured by NCI-CTCAE v 4.0. Must be ≥ 3 months beyond completion of chemotherapy. Not planning to receive concurrent chemotherapeutic agents during the study period.

Patients with diabetes mellitus, peripheral vascular disease, HIV infection, or a significant degenerative or familial neurologic can be included in the study provided they don't have peripheral neuropathy secondary to above mentioned diseases.

Allowable types and amount of prior therapy for neuropathy:

  • Patients receiving analgesics for pain associated with CIPN are eligible provided they have taken the same dosage and same medication for at least 2 weeks prior to the study initiation.
  • Patients on antidepressants regimens of Selective Serotonin Reuptake Inhibitors (SSRI) or Selective serotonin norepinephrine reuptake inhibitors (SSNRI) for treatment of anxiety or depression, anticonvulsants or mexiletine for the treatment of pain are eligible provided they are on stable dose for 30 days.

Age ≥ 18 years. Both men and women of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

Any pain other than neuropathic pain of equal or greater severity. Patients with sensory polyneuropathy due to AIDS/HIV, complex regional pain syndrome, and Trigeminal neuralgia.

History of suicidal ideation. Patients with a history of non-compliance. Patients who are judged by the investigator to be unable or unlikely to understand the nature, scope, and possible consequences of the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709888


Contacts
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Contact: Jaya M Gill, BSN, RN 3105827437 jaya.gill@providence.org
Contact: Marlon Saria, PhD, RN 3105827340 sariam@jwci.org

Locations
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United States, California
John Wayne Cancer Institute at Providence Saint John's Health Center Recruiting
Santa Monica, California, United States, 90404
Contact: Marlon G. Saria, PhD, RN       neuro.oncology@jwci.org   
Sponsors and Collaborators
John Wayne Cancer Institute
Investigators
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Principal Investigator: Santosh Kesari, MD, PhD John Wayne Cancer Institute

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Responsible Party: Santosh Kesari, Professor and Director, John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT03709888     History of Changes
Other Study ID Numbers: JWCI-17-0101
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Memantine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents