Study on High-Dose Vitamin C with Radiation Therapy for Pancreatic Cancer Patients

Sponsor: Joseph J. Cullen, MD, FACS

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03541486

Provider View

This clinical trial is exploring whether high doses of vitamin C can help reduce side effects and improve survival in pancreatic cancer patients undergoing radiation therapy. The study will also gather information on patients' experiences during treatment.

Patient Parameters

Program Overview

Radiation therapy is used to kill cancer cells but can also harm healthy organs, leading to long-term side effects. This study aims to find out if high doses of vitamin C can reduce these side effects and improve survival rates for pancreatic cancer patients. Participants will be monitored throughout the study to understand their experiences and any side effects they encounter. The research could lead to new ways to help cancer survivors avoid lasting side effects from treatments.

Description

This study is testing whether high doses of vitamin C, given along with radiation therapy, can help pancreatic cancer patients. Participants will be randomly assigned to receive either the standard treatment (radiation and chemotherapy) or the standard treatment plus high-dose vitamin C. The vitamin C is given through an IV before, during, and after radiation therapy sessions. Each dose of vitamin C is equivalent to the amount found in about 1,000 oranges.

Participants will:

  • Be randomly assigned to receive either the investigational treatment (vitamin C plus standard treatment) or just the standard treatment.
  • Receive chemotherapy (gemcitabine) once a week for up to 6 weeks.
  • Undergo radiation therapy once a day, Monday through Friday.
  • Attend regular doctor's visits and report any side effects.
  • Participate in interviews to discuss how side effects affect their daily life.
  • Receive vitamin C infusions during radiation therapy if assigned to the investigational group.

After completing radiation therapy, participants will continue with follow-up care to monitor long-term side effects, which may take years to develop. Follow-up visits will include interviews to assess the impact of side effects on quality of life.

Eligibility Criteria

Inclusion Criteria

  • Must be able and willing to provide informed consent.
  • Willing to follow all study procedures and be available for the study duration.
  • At least 18 years old.
  • Diagnosed with pancreatic adenocarcinoma.
  • Referred for gemcitabine-based chemoradiation.
  • In good health with a performance status score of 0, 1, or 2.
  • No other active cancer needing immediate treatment.
  • No uncontrolled illnesses that would interfere with the study.
  • Agree to avoid alcohol and certain supplements during the study.

Exclusion Criteria

  • Have a deficiency in glucose-6-phosphate dehydrogenase (G6PD).
  • HIV positive and on anti-retroviral therapy.
  • Low platelet count (less than 100,000).
  • Previous radiation that overlaps with the study's treatment area.
  • Cancer that has spread beyond nearby lymph nodes.
  • Currently using insulin.
  • Received other therapy within 2 weeks of the study.
  • Taking certain medications that cannot be substituted.
  • Participating in other investigational treatments.
  • Pregnant or not using birth control.
  • Breastfeeding and unwilling to stop during the study.

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