Memantine XR and Pregabalin for Chemotherapy-Induced Peripheral Neuropathy

NCT ID: NCT03709888

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-09
• Study Completion Date: 2021-04-29

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.

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Memantine XR-pregabalin combination therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Namenda XR-Lyrica

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint John's Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Santosh Kesari

Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Santosh Kesari, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Saint John's Cancer Institute

Locations

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

Santa Monica, California, United States

Countries

United States

Other Identifiers

JWCI-17-0101

Identifier Type: -

Identifier Source: org_study_id