Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer — PTCA199-4  

Metastatic Pancreatic Cancer Clinical Trial

Official title: Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of vitamin C in improving the quality of life for metastatic pancreatic cancer patients who are resistant to chemotherapy.

Clinical Trial Description

Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, a trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity. In 2013, the Metastatic PAncreatic Cancer Trial (MPACT) has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the side-effects related to chemotherapy including anemia, hand/foot numbness, fatigue, nausea, and malnutrition have impaired the quality of life for patients.

Vitamin C, also called ascorbate, is an essential nutrient for the human body. It modulates metabolism, immune reaction, collagen synthesis, and iron absorption. Some studies have shown that high-dose intravenous Vitamin C may be effective against various types of cancer. Meanwhile, medium or low dose of Vitamin C may increase iron absorption, improve anemia, alleviate pain and hand/foot numbness, and thus improve the quality of life for patients with terminal stage pancreatic cancer.

The purpose of this study is to evaluate the efficacy of vitamin C on improving the quality of life for metastatic pancreatic cancer patients who are resistant to two lines of systemic chemotherapy, including gemcitabine based, fluorouracil based, or other regimen. Twenty patients who have tumor progression after receiving two lines of chemotherapy will be recruited. These patients will receive Vitamin C and the dosage is based on the concentration of baseline serum Vitamin C concentration. Quality of life, rate of hand/foot numbness, severity of pain, rate of anemia, and overall survival are measured every four weeks. ;

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms
• Terminal Cancer

• NCT number: NCT06018896
• Study type: Interventional
• Source: Fudan University
• Contact: Ying Yang, MD
• Phone: 86 21 64175590
• Email: yangying@fudanpci.org
• Status: Recruiting
• Phase: Phase 2
• Start date: August 25, 2023
• Completion date: August 15, 2026