A Phase 3 interventional study of Ascorbate and Nab paclitaxel in Metastatic Pancreatic Adenocarcinoma, sponsored by Fudan University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by Fudan University · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of low-dose vitamin C on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel 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. 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 gemcitabine combined with nab-paclitaxel including anemia, hand/foot numbness, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen.
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 enhance the tolerability of chemotherapy by increasing iron absorption, improving anemia, alleviating pain and hand/foot numbness, and thus improving quality of life for patients with pancreatic cancer.
The purpose of this study is to evaluate the efficacy of low-dose vitamin C on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy. One hundred patients will be randomly assigned to the experimental group (gemcitabine combined with nab-paclitaxel, Vitamin C) or the control group (gemcitabine combined with nab-paclitaxel). Rate of anemia, rate of hand/foot numbness, severity of pain, quality of life, and overall survival are measured every four weeks.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's planned enrollment of 100 is close to the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
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Exclusion Criteria:
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Vitamin C 900 mg/day, three times a day, orally.
Drug: Ascorbate · Drug: Nab paclitaxel · Drug: Gemcitabine
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
Drug: Nab paclitaxel · Drug: Gemcitabine
Vitamin C 900 mg/day, three times a day, orally.
Also known as: Vitamin C
Nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks
Also known as: Nab-paclitaxel
Gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks
Also known as: Gemcitabine Hydrochloride
Rate of anemia
Rate of anemia after every cycle of chemotherapy
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Rate of grade 3 neuropathy
Rate of grade 3 neuropathy after every cycle of chemotherapy
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Change of numeric rating scale (NRS)
Change of NRS and the administration of analgesic drugs after every cycle of chemotherapy. The range of NRS scale is 0-10 and higher scores mean a worse outcome.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Quality of life (QOL)
Change of QOL after every cycle of chemotherapy assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Overall survival (OS)
OS of subjects from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Plan to share: No
This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Fudan University