Vitamin C Plus Cordyceps To Chemotherapy Related Anemia In Pancreatic Cancer

Study Overview

Vitamin C Plus Cordyceps to Chemotherapy Related Anemia in Pancreatic Cancer

The purpose of this study is to evaluate the efficacy of low-dose vitamin C plus herbal medicine on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy.

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. 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 gemcitabine combined with nab-paclitaxel including anemia, hand/foot numbness, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen. 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 enhance the tolerability of chemotherapy by increasing iron absorption, improving anemia, alleviating pain and hand/foot numbness, and thus improving quality of life for patients with 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 low-dose vitamin C plus herbal medicine (Reishi and Cordyceps) on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy. Fifty patients will be assigned to the experimental group (gemcitabine combined with nab-paclitaxel, Vitamin C, Reishi and Cordyceps). Rate of anemia, rate of hand/foot numbness, severity of pain, quality of life, and overall survival are measured.

Pancreatic Cancer

DRUG: Vitmain C plus herbal medicine

PTCA199-12

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-09-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-11-22
First Submitted that Met QC Criteria 2024-09-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-11-26
First Posted (ACTUAL) 2024-09-19	Results First Posted N/A	Last Verified 2024-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: VC plus herbal medicine nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Vitamin C 300 mg/day, TID, PO. Reishi, 2 g/day, BID, PO. Cordyceps, 2 g/day, BID, PO.	DRUG: Vitmain C plus herbal medicine nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Vitamin C 300 mg/day, TID, PO. Reishi, 2 g/day, BID, PO. Cordyceps, 2 g/day, BID, PO.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: VC plus herbal medicine

nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Vitamin C 300 mg/day, TID, PO. Reishi, 2 g/day, BID, PO. Cordyceps, 2 g/day, BID, PO.

DRUG: Vitmain C plus herbal medicine

nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Vitamin C 300 mg/day, TID, PO. Reishi, 2 g/day, BID, PO. Cordyceps, 2 g/day, BID, PO.

Primary Outcome Measures	Measure Description	Time Frame
Rate of anemia	Rate of anemia after every cycle of chemotherapy	At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcome Measures	Measure Description	Time Frame
Rate of Grade 3 neuropathy	Rate of Grade 3 neuropathy after every cycle of chemotherapy	At the end of Cycle 1 (each cycle is 28 days)
Change of numeric rating scale, NRS	Change of NRS and the administration of analgesic drugs after every cycle of chemotherapy	At the end of Cycle 1 (each cycle is 28 days)
Quality of life, QOL	Change of QOL after every cycle of chemotherapy	At the end of Cycle 1 (each cycle is 28 days)
Overall survival，OS	OS of subjects from randomization to the time of death from any cause	At the end of Cycle 1 (each cycle is 28 days)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Huanyu Xia, MD

Phone Number: 86 21 64031446

Email: xianhuanyu@fudanpci.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

• 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.

• 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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.

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