Memantine XR and Pregabalin for Chemotherapy-Induced Peripheral Neuropathy
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|ClinicalTrials.gov Identifier: NCT03709888|
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : November 13, 2020
|Condition or disease||Intervention/treatment|
|Chemotherapy-induced Peripheral Neuropathy||Drug: Memantine XR-pregabalin combination therapy|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||An Observational Study Efficacy and Safety of Memantine XR (Extended Release) and Pregabalin Combination Therapy in Chemotherapy-Induced Peripheral Neuropathy (CIPN)|
|Actual Study Start Date :||July 9, 2018|
|Estimated Primary Completion Date :||December 18, 2022|
|Estimated Study Completion Date :||December 18, 2022|
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
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.
Other Name: Namenda XR-Lyrica
- Change in average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF) [ Time Frame: 6 weeks ]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.
- 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) [ Time Frame: 6 weeks ]Absolute change in the QoL measured by European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) after 6 weeks of treatment compared to baseline. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
- Change in the intensity of mechanical allodynia measured using qualitative sensory testing [ Time Frame: 6 weeks ]Absolute change in mechanical allodynia intensity after 6 weeks of treatment compared to baseline. Testing is done by touching the sensitive (neuropathic) area with a foam brush 3 times in 5 secs and asking the patient about their pain score before and after the procedure.
- Change in neuropathic symptoms as measured by Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: 6 weeks ]Absolute change in neuropathic symptoms measured by Neuropathic Pain Symptom Inventory (NPSI) scores after 6 weeks of treatment compared to baseline. A total intensity score can be calculated as the sum of the scores of the 10 descriptors ranging from 0 to 100. Five subscores corresponding to the mean scores of the items belonging to each of the five dimensions ranging from 0 to 10. ) is "no pain" and 10 is "the most intense pain imaginable".
- Change in reported sleep interference as measured by item # 9 of Brief Pain Inventory- Short Form (BPI-SF) [ Time Frame: 6 weeks ]Absolute change in sleep interference measured by item # 9 of Brief Pain Inventory Score (BPI-SF) after 6 weeks of treatment from baseline. Score for question 9F for sleep ranges from 0 "does not interfere" to 10 "completely interferes".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709888
|Contact: Jaya M Gill, BSN, RNfirstname.lastname@example.org|
|Contact: Marlon Saria, PhD, RNemail@example.com|
|United States, California|
|John Wayne Cancer Institute at Providence Saint John's Health Center||Recruiting|
|Santa Monica, California, United States, 90404|
|Contact: Marlon G. Saria, PhD, RN firstname.lastname@example.org|
|Principal Investigator:||Santosh Kesari, MD, PhD||John Wayne Cancer Institute|