Digestive System Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Liver Cirrhosis

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Fibrosis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Anti-Dyskinesia Agents

Cardiotonic Agents

Liver Extracts

Memantine

Antiparkinson Agents

Dopamine

Dopamine Agents

Neurotransmitter Agents

Excitatory Amino Acid Antagonists

Memantine 5 mg by mouth once daily, to be titrated up to 20 mg daily

Namenda

Elahe Mollapour

Keary Jane't

Arthur Winer, MD

Arthur Winer

This is a single-site prospective study to describe efficacy endpoints of single agent memantine in patients with unresectable, locally advanced, or metastatic HCC otherwise not deemed candidates for intensive systemic therapy. In addition to the primary endpoint and multiple secondary efficacy endpoints, we will describe changes in quality of life on treatment over time.

A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer

A Prospective Cohort Study of Single Agent Memantine in Patients With Child-Pugh Score ≥ B7 Cirrhosis and Hepatocellular Carcinoma

The EORTC QLQ-C30 consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each score is transformed onto a 0 to 100 point scale. For the symptom scales and single items, a higher score implies a high level of symptoms or problems. Previously published minimally important differences will be used to identify meaningful changes from baseline in each treatment group on the disease and treatment-related symptom scales.

The EORTC QLQ-HCC18 is a disease-specific measure which contains five multi-item symptom scales (fatigue, body image, jaundice, nutrition, and fever), and four single-item measures (shoulder pain, abdominal pain, abdominal swelling, and sex life) for a total of 18 questions with a recall period of the previous week. The EORTC QLQ-HCC18 module takes approximately 5 minutes to complete. All item responses are scored according to the EORTC guidelines for scoring.

The response and progression will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. The progression of the disease is defined as at least a 20% increase in the sum of the Longest Diameter LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions or death due to disease without objective evidence of progression.

Inova Health Care Services

Spots Global Cancer Trial Database for A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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