Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
ID06018896

Vitamin C to Improve Quality of Life in Patients With Terminal Stage Metastatic Pancreatic Cancer

Led by Fudan University · Updated on 2024-06-06

20

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effects of vitamin C on improving the quality of life for patients with metastatic pancreatic cancer who have not responded to two lines of chemotherapy. Pancreatic cancer is a very serious illness with low survival rates, and many patients experience severe side effects from chemotherapy that reduce their quality of life. The study focuses on patients whose cancer has progressed despite previous treatments and seeks to find if vitamin C can help ease symptoms and improve well-being. Participants will receive vitamin C based on their measured baseline serum vitamin C levels. Those with lower levels will start with intravenous vitamin C at doses of 10 g, 4 g, and 2 g each given for seven days, followed by oral vitamin C at 900 mg taken three times daily. Patients with higher baseline levels will take oral vitamin C at the same dose. Treatment cycles last 28 days and continue with monitoring throughout. During the study, researchers will assess participants every four weeks to measure quality of life, the occurrence of hand and foot numbness, pain severity, anemia rates, and overall survival. These evaluations include physical assessments, questionnaires, and laboratory tests. The study will last until August 2026, and participants will be closely monitored to track changes and safety throughout the trial period.

CONDITIONS

Brief Title

Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and willingly sign informed consent
  • Age 18 to 80 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma
  • Tumor progression after two lines of chemotherapy
  • Adequate organ function based on laboratory tests
  • At least one measurable lesion per RECIST criteria
  • Expected survival of at least 1 month
  • Women of childbearing potential and men must agree to use contraception during study participation
Not Eligible

You will not qualify if you...

  • Active second primary malignancy or history of second primary malignancy
  • Diagnosis of non-adenocarcinoma pancreatic cancer
  • Inflammation of the digestive tract, such as pancreatitis, cholecystitis, or cholangitis
  • Pregnant or nursing women
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Severe diseases that affect study compliance or result interpretation
  • Renal insufficiency or dialysis
  • Other serious illnesses affecting treatment safety
  • Unwillingness or inability to comply with study procedures

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Repeated 28-day cycles until disease progression or discontinuation

Participants receive Vitamin C treatment based on their baseline serum Vitamin C concentration to improve quality of life and alleviate symptoms related to terminal stage metastatic pancreatic cancer.

Visits every 4 weeks for assessments

Trial Site Locations

Total: 1 location

1

Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

Y

Ying Yang, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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