Actively Recruiting
Vitamin C to Improve Quality of Life in Patients With Terminal Stage Metastatic Pancreatic Cancer
Led by Fudan University · Updated on 2024-06-06
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of vitamin C on improving the quality of life for patients with metastatic pancreatic cancer who have not responded to two lines of chemotherapy. Pancreatic cancer is a very serious illness with low survival rates, and many patients experience severe side effects from chemotherapy that reduce their quality of life. The study focuses on patients whose cancer has progressed despite previous treatments and seeks to find if vitamin C can help ease symptoms and improve well-being. Participants will receive vitamin C based on their measured baseline serum vitamin C levels. Those with lower levels will start with intravenous vitamin C at doses of 10 g, 4 g, and 2 g each given for seven days, followed by oral vitamin C at 900 mg taken three times daily. Patients with higher baseline levels will take oral vitamin C at the same dose. Treatment cycles last 28 days and continue with monitoring throughout. During the study, researchers will assess participants every four weeks to measure quality of life, the occurrence of hand and foot numbness, pain severity, anemia rates, and overall survival. These evaluations include physical assessments, questionnaires, and laboratory tests. The study will last until August 2026, and participants will be closely monitored to track changes and safety throughout the trial period.
CONDITIONS
Brief Title
Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willingly sign informed consent
- Age 18 to 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma
- Tumor progression after two lines of chemotherapy
- Adequate organ function based on laboratory tests
- At least one measurable lesion per RECIST criteria
- Expected survival of at least 1 month
- Women of childbearing potential and men must agree to use contraception during study participation
You will not qualify if you...
- Active second primary malignancy or history of second primary malignancy
- Diagnosis of non-adenocarcinoma pancreatic cancer
- Inflammation of the digestive tract, such as pancreatitis, cholecystitis, or cholangitis
- Pregnant or nursing women
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Severe diseases that affect study compliance or result interpretation
- Renal insufficiency or dialysis
- Other serious illnesses affecting treatment safety
- Unwillingness or inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive Vitamin C treatment based on their baseline serum Vitamin C concentration to improve quality of life and alleviate symptoms related to terminal stage metastatic pancreatic cancer.
Visits every 4 weeks for assessments
Trial Site Locations
Total: 1 location
1
Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Y
Ying Yang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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