Memantine XR and Pregabalin for Chemotherapy-Induced Peripheral Neuropathy

NCT03709888 | Completed FDA Drug

• 1 other identifier: JWCI-17-0101
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change in average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF)

  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.

  6 weeks

Secondary Outcomes (4)

• 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)

  6 weeks

• Change in the intensity of mechanical allodynia measured using qualitative sensory testing

  6 weeks

• Change in neuropathic symptoms as measured by Neuropathic Pain Symptom Inventory (NPSI)

  6 weeks

• Change in reported sleep interference as measured by item # 9 of Brief Pain Inventory- Short Form (BPI-SF)

  6 weeks

Study Arms (1)

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

Interventions

Memantine XR-pregabalin combination therapy DRUG

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.

Also known as: Namenda XR-Lyrica

Observation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint John's Cancer Institute: lead

Study Sites (1)

John Wayne Cancer Institute at Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

Study Officials

• Santosh Kesari, MD, PhD

  Saint John's Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: October 17, 2018
• Study Start: July 9, 2016
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

US (1)