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An Observational Study Efficacy and Safety of Memantine XR (Extended Release) and Pregabalin Combination Therapy in Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
John Wayne Cancer Institute at Providence Saint John's Health Center
Santa Monica, California, United States
Start Date
July 9, 2016
Primary Completion Date
April 29, 2021
Completion Date
April 29, 2021
Last Updated
April 6, 2022
20
ACTUAL participants
Memantine XR-pregabalin combination therapy
DRUG
Lead Sponsor
Saint John's Cancer Institute
NCT07352514
NCT07064798
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