Using low-dose vitamin C to help with anemia in pancreatic cancer patients undergoing chemotherapy
Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer
This study is testing if low-dose vitamin C can help people with pancreatic cancer feel better and manage side effects like anemia while they are getting chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06018883 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of low-dose vitamin C in improving the quality of life for patients with metastatic pancreatic adenocarcinoma who are receiving gemcitabine and nab-paclitaxel chemotherapy. The trial will randomly assign 100 participants to either receive the chemotherapy regimen with vitamin C or the chemotherapy alone. The focus is on addressing chemotherapy-related side effects such as anemia, fatigue, and pain, which can significantly impact patient well-being. By enhancing iron absorption and potentially alleviating these side effects, the study aims to improve overall treatment tolerability and patient quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed metastatic pancreatic adenocarcinoma and an ECOG performance status of 0-2.
Not a fit: Patients who have received prior anti-tumor therapy or have non-adenocarcinoma pancreatic diagnoses will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life for patients undergoing chemotherapy for pancreatic cancer.
How similar studies have performed: While some studies have explored high-dose vitamin C in cancer treatment, the use of low-dose vitamin C in this specific context is relatively novel and has not been extensively tested.
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 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.
Where this trial is running
Shanghai, Shanghai
- Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Guopei Luo, MD — Fudan University
- Study coordinator: Ying Yang, MD
- Email: yangying@fudanpci.org
- Phone: 86 21 64175590
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.