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Trial Title:
Vitamin C Plus Herbal Medicine to Quality of Life in Patients with Terminal Stage Pancreatic Cancer
NCT ID:
NCT06598033
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Pancreatic cancer
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
VC plus herbal medicine
Description:
Vitamin C 300 mg/day, TID, PO. Reishi, 2 g/day, BID, PO. Cordyceps, 2 g/day, BID, PO.
Arm group label:
VC plus herbal medicine
Summary:
The purpose of this study is to evaluate the efficacy of vitamin C plus herbal medicine
in improving the quality of life for metastatic pancreatic cancer patients who are
resistant to chemotherapy.
Detailed description:
Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%.
Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage.
Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the
PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin
(FOLFIRINOX) was associated with a survival advantage but had increased toxicity. In
2013, the MPACT trial has confirmed the efficacy of gemcitabine combined with
nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the
side-effects related to chemotherapy including anemia, hand/foot numbness, fatigue,
nausea, and malnutrition have impaired the quality of life for patients.
Vitamin C, also called ascorbate, is an essential nutrient for the human body. It
modulates metabolism, immune reaction, collagen synthesis, and iron absorption. Some
studies have shown that high-dose intravenous Vitamin C may be effective against various
types of cancer. Meanwhile, medium or low dose of Vitamin C may increase iron absorption,
improve anemia, alleviate pain and hand/foot numbness, and thus improve the quality of
life for patients with terminal stage pancreatic cancer. In addition, numerous evidence
has proved the efficacy of Reishi and Cordyceps in alleviating the side effects related
to chemotherapy.
The purpose of this study is to evaluate the efficacy of vitamin C plus herbal medicine
on improving the quality of life for metastatic pancreatic cancer patients who are
resistant to two lines of systemic chemotherapy, including gemcitabine based,
fluorouracil based, or other regimen. Fifty patients who have tumor progression after
receiving two lines of chemotherapy will be recruited. These patients will receive
Vitamin C plus herbal medicine. Quality of life, rate of hand/foot numbness, severity of
pain, rate of anemia, and overall survival are measured.
Criteria for eligibility:
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 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:
- • 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
October 1, 2024
Completion date:
October 1, 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06598033
