Vitamin C Plus Cordyceps to Quality of Life in Patients With Terminal Stage Pancreatic Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Huanyu Xia, MD
- Phone Number: 86 21 64031446
- Email: xianhuanyu@fudanpci.org
Study Locations
-
-
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Shanghai, China
- Recruiting
- Shanghai Cancer Center
-
Contact:
- Yi Li, MD
- Phone Number: 1307 86 21 64175590
- Email: liuyi@fudanpci.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 treatments.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VC plus herbal medicine
Vitamin C 300 mg/day, TID, PO.
Reishi, 2 g/day, BID, PO.
Cordyceps, 2 g/day, BID, PO.
|
Vitamin C 300 mg/day, TID, PO.
Reishi, 2 g/day, BID, PO.
Cordyceps, 2 g/day, BID, PO.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life (QOL) questionnaire
Time Frame: 1 month
|
Change of QOL after every cycle of treatment using ORTC QLQ-C30 (version 3).
Scale 1-7, higher scores mean a better outcome.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of hand-foot skin reaction, HFSR
Time Frame: 1 month
|
Rate of HFSR after every cycle of treatment
|
1 month
|
|
Rate of anemia
Time Frame: 1 month
|
Rate of anemia after every cycle of treatment
|
1 month
|
|
Overall survival，OS
Time Frame: 1 month
|
OS of subjects from recruiting to the time of death from any cause
|
1 month
|
|
Change of numeric rating scale (NRS)
Time Frame: 1 month
|
Change of numeric rating scale (NRS) and the administration of analgesic drugs after every cycle of treatment.
NRS scale 0-10.
Higher scores mean a worse outcome.
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guopei Luo, MD, Shanghai Cancer Center
Publications and helpful links
General Publications
- Das G, Shin HS, Leyva-Gomez G, Prado-Audelo MLD, Cortes H, Singh YD, Panda MK, Mishra AP, Nigam M, Saklani S, Chaturi PK, Martorell M, Cruz-Martins N, Sharma V, Garg N, Sharma R, Patra JK. Cordyceps spp.: A Review on Its Immune-Stimulatory and Other Biological Potentials. Front Pharmacol. 2021 Feb 8;11:602364. doi: 10.3389/fphar.2020.602364. eCollection 2020.
- Sohretoglu D, Huang S. Ganoderma lucidum Polysaccharides as An Anti-cancer Agent. Anticancer Agents Med Chem. 2018;18(5):667-674. doi: 10.2174/1871520617666171113121246.
- Wang X, Zhu X, Liu Y, Liu H, Xiao Z, Luo G. Efficacy of vitamin C on chemotherapy-related anemia in pancreatic cancer: study protocol for a randomized controlled trial. Trials. 2024 Jul 29;25(1):512. doi: 10.1186/s13063-024-08345-w.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTCA199-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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