RecruitingPhase 2Phase 3NCT06601283

Vitamin C Plus Cordyceps to Chemotherapy Related Anemia in Pancreatic Cancer

Sponsor

Fudan University

Enrollment

50 participants

Start Date

Nov 22, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer

Summary

The purpose of this study is to evaluate the efficacy of low-dose vitamin C plus herbal medicine on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria9

• 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 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 Criteria11

• Patients who have received anti-tumor treatment for other types of cancer in the last two years.
Patients who have received any form of anti-tumor therapy for pancreatic cancer.
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.

Interventions

DRUGVitmain C plus herbal medicine

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 300 mg/day, TID, PO. Reishi, 2 g/day, BID, PO. Cordyceps, 2 g/day, BID, PO.