Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer

Launched by FUDAN UNIVERSITY · Aug 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of low-dose vitamin C on improving the quality of life for patients with metastatic pancreatic cancer who are undergoing chemotherapy with gemcitabine and nab-paclitaxel. The researchers want to see if vitamin C can help reduce anemia, a condition where you have low levels of red blood cells, which can make you feel tired and weak.

To participate in the trial, you must be between 18 and 80 years old and have a confirmed diagnosis of metastatic pancreatic adenocarcinoma. You should also have certain health conditions under control and have a measurable tumor. If you join the study, you'll receive treatment and undergo regular check-ups to monitor your progress. It's important to note that participants will need to agree to use contraception during the study, and those with severe health issues or certain medical histories may not be eligible. If you're interested in this trial, it's a great opportunity to contribute to research that could help improve the lives of others facing similar challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Ability to understand and the willingness to sign a written informed consent document.
• • Age ≥ 18 years and ≤ 80 years.
• • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• • Histologically or cytologically confirmed metastatic pancreas adenocarcinoma.
• • Adequate organ performance based on laboratory blood tests.
• • Presence of at least of one measurable lesion in agreement to Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
• • Hemoglobin (Hgb) ≥ 8 g/dL.
• • The expected survival ≥ 3 months.
• • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
• Exclusion Criteria:
• • Patients who have received any form of anti-tumor therapy.
• • The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
• • Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
• • Pregnant or nursing women.
• • Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• • Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines, uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, congestive heart failure (CHF), myocardial infarction in the past 6 months , unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc).
• • Renal insufficiency or dialysis
• • History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, or other agents used in the study.
• • Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
• • Patients who are unwilling or unable to comply with study procedures.