The purpose of this study is to evaluate the efficacy of vitamin C plus herbal medicine in improving the quality of life for metastatic pancreatic cancer patients who are resistant to chemotherapy.
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, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity. In 2013, the MPACT trial 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. In addition, numerous evidence has proved the efficacy of Reishi and Cordyceps in alleviating the side effects related to chemotherapy. The purpose of this study is to evaluate the efficacy of vitamin C plus herbal medicine 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. Fifty patients who have tumor progression after receiving two lines of chemotherapy will be recruited. These patients will receive Vitamin C plus herbal medicine. Quality of life, rate of hand/foot numbness, severity of pain, rate of anemia, and overall survival are measured.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Vitamin C 300 mg/day, TID, PO. Reishi, 2 g/day, BID, PO. Cordyceps, 2 g/day, BID, PO.
Shanghai Cancer Center
Shanghai, China
RECRUITINGQuality of life (QOL) questionnaire
Change of QOL after every cycle of treatment using ORTC QLQ-C30 (version 3). Scale 1-7, higher scores mean a better outcome.
Time frame: 1 month
Rate of hand-foot skin reaction, HFSR
Rate of HFSR after every cycle of treatment
Time frame: 1 month
Rate of anemia
Rate of anemia after every cycle of treatment
Time frame: 1 month
Overall survival，OS
OS of subjects from recruiting to the time of death from any cause
Time frame: 1 month
Change of numeric rating scale (NRS)
Change of numeric rating scale (NRS) and the administration of analgesic drugs after every cycle of treatment. NRS scale 0-10. Higher scores mean a worse outcome.
Time frame: 1 month
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