Using Vitamin C and Cordyceps to Help Anemia in Pancreatic Cancer Patients
Vitamin C Plus Cordyceps to Chemotherapy Related Anemia in Pancreatic Cancer
This study is testing if low-dose vitamin C and herbal medicine can help improve the quality of life for pancreatic cancer patients dealing with anemia while receiving chemotherapy.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06601283 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of low-dose vitamin C combined with herbal medicine (Reishi and Cordyceps) in improving the quality of life for patients with metastatic pancreatic cancer undergoing chemotherapy with gemcitabine and nab-paclitaxel. Given the severe side effects of chemotherapy, including anemia and fatigue, the study aims to determine if these supplements can enhance tolerability and overall well-being. Participants will be monitored for improvements in symptoms and quality of life metrics throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with confirmed metastatic pancreatic adenocarcinoma and specific performance status criteria.
Not a fit: Patients who have received prior anti-tumor treatment for pancreatic cancer or have non-adenocarcinoma types of pancreatic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients undergoing chemotherapy for pancreatic cancer.
How similar studies have performed: While some studies have shown promise with high-dose vitamin C in cancer treatment, the combination of low-dose vitamin C with herbal medicine in this specific context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 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.
Where this trial is running
Shanghai
- Shanghai Cancer Center — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Huanyu Xia, MD
- Email: xianhuanyu@fudanpci.org
- Phone: 86 21 64031446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.