Vitamin C for improving quality of life in patients with terminal pancreatic cancer
Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer
This study is testing if vitamin C can help improve the quality of life for patients with advanced pancreatic cancer who haven't had success with other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06018896 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of vitamin C in enhancing the quality of life for patients suffering from metastatic pancreatic cancer who have not responded to two lines of chemotherapy. Given the severe side effects of chemotherapy, such as anemia and fatigue, the study aims to determine if vitamin C can alleviate these symptoms and improve overall well-being. Participants will receive ascorbate treatment while being monitored for changes in their quality of life. The study focuses on patients with confirmed metastatic pancreatic adenocarcinoma and measurable lesions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with metastatic pancreatic adenocarcinoma who have experienced tumor progression after two lines of chemotherapy.
Not a fit: Patients with active second primary malignancies or those whose pancreatic cancer is not adenocarcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the quality of life for patients with terminal pancreatic cancer.
How similar studies have performed: While some studies have suggested that high-dose vitamin C may be effective against various cancers, this specific approach for terminal pancreatic cancer 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. * Tumor progression after two lines of chemotherapy. * 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. * The expected survival ≥ 1 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: * Active second primary malignancy or history of second primary malignancy. * 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. * Renal insufficiency or dialysis * 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 Municipality
- Shanghai Cancer Center — Shanghai, Shanghai Municipality, 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.