Overview

Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer

Status:
Recruiting
Trial end date:
2026-08-15
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Treatments:
Albumin-Bound Paclitaxel
Gemcitabine
Paclitaxel
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.