Memantine XR and Pregabalin for Chemotherapy-Induced Peripheral Neuropathy

  • STATUS
    Recruiting
  • End date
    Dec 18, 2022
  • participants needed
    20
  • sponsor
    John Wayne Cancer Institute
Updated on 26 January 2021
analgesics
paclitaxel
cancer
diabetes mellitus
vincristine
lenalidomide
norepinephrine
oxaliplatin
carboplatin
docetaxel
bortezomib
selective serotonin reuptake inhibitors
peripheral neuropathy
neuralgia
alkaloids
antineoplastic drugs
mexiletine

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 InventoryShort 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.

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.

Details
Condition Chemotherapy Induced Peripheral Neuropathy
Treatment Memantine XR-pregabalin combination therapy
Clinical Study IdentifierNCT03709888
SponsorJohn Wayne Cancer Institute
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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