Vitamin C Plus Cordyceps to Chemotherapy Related Anemia in Pancreatic Cancer

Last updated: November 22, 2024
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

2/3

Condition

Pancreatic Cancer

Digestive System Neoplasms

Pancreatitis

Treatment

Vitmain C plus herbal medicine

Clinical Study ID

NCT06601283
PTCA199-12
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Ability to understand and the willingness to sign a written informed consentdocument.

  • 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 adequatecontraception prior to study entry and for the duration of study participation.

Exclusion

Exclusion Criteria:

  • • Patients who have received anti-tumor treatment for other types of cancer in thelast two years.

  • Patients who have received any form of anti-tumor therapy for pancreaticcancer.

  • 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 protocolcompliance or interfere with the interpretation of results, including activeopportunistic infections or advanced (severe) infections, and diabetes thatcannot be controlled after adequate clinical anti-hyperglycemia treatmentaccording to guidelines, uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Associationclassification, congestive heart failure (CHF), myocardial infarction in thepast 6 months , unstable arrhythmia or unstable angina, cerebral infarctionwithin 3 months, etc).

  • Renal insufficiency or dialysis

  • History of allergic reactions attributed to compounds of similar chemical orbiologic composition to gemcitabine, nab-paclitaxel, or other agents used inthe 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.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Vitmain C plus herbal medicine
Phase: 2/3
Study Start date:
November 22, 2024
Estimated Completion Date:
November 22, 2027

Study 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. 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.

Connect with a study center

  • Shanghai Cancer Center

    Shanghai, 200032
    China

    Active - Recruiting

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