Clinical trial NCT03709888: Memantine XR and Pregabalin for Chemotherapy-Induced Peripheral Neuropathy
Official title: An Observational Study Efficacy and Safety of Memantine XR (Extended Release) and Pregabalin Combination Therapy in Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Saint John's Cancer Institute
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Change in average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF)
timeFrame: 6 weeks
Secondary outcomes:
measure: 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)
timeFrame: 6 weeks
measure: Change in the intensity of mechanical allodynia measured using qualitative sensory testing
timeFrame: 6 weeks
measure: Change in neuropathic symptoms as measured by Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: 6 weeks
measure: Change in reported sleep interference as measured by item # 9 of Brief Pain Inventory- Short Form (BPI-SF)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute at Providence Saint John's Health Center
state: California
Study officials:
affiliation: Saint John's Cancer Institute
name: Santosh Kesari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: