Pancreatic Cancer Research

Clinical trialPhase 1Completed

New Treatment Option for Pancreatic Cancer

Translation of in Vitro and in Vivo Ascorbate Research Into a New Treatment Option for Pancreatic Cancer: Phase I/IIa Clinical Trial

Outcome
Finished, no results posted
Phase
Phase 1
Status
Completed
Study type
Interventional
Start
April 2011
Expected end
October 2015
Enrollment
14 participants
Sites
1
Primary outcomes
Determine safety of combined gemcitabine chemotherapy with IV ascorbate.
Sponsor
Other
Results posted
No
Last update
19 June 2018

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Brief summary public domain (ClinicalTrials.gov)

In the United States, approximately 30,000 new cases of pancreatic cancer are diagnosed each year and an almost equal number of deaths are related to this cancer. Different types of chemotherapeutic treatments are used that target different parts of the cancer cell with some success, but there is room for other treatment options. It is known that people with cancer are using high doses of intravenous vitamin C also known as ascorbate, as a cancer treatment and this is occurring frequently. When Vitamin C is given in this manner, it is not taken by mouth; instead, it enters your body through an IV (intravenous) site, or tube that is inserted through a needle into your vein. If you have a port-a-cath in place, the IV will be given using your port. When Vitamin C enters your body through an IV site, it is known that it acts like a drug and not a vitamin. It produces a substance around the cancer cells called hydrogen peroxide. It has been seen in animal research studies that hydrogen peroxide kills the cancer cells while leaving the normal cells unharmed. Currently the FDA does not approve the use of high-dose intravenous Vitamin C as a cancer treatment. The use of intravenous Vitamin C in this study is experimental. Furthermore, it is important to know that we do not expect the intravenous Vitamin C given in this study to be healing for the treatment of your cancer.

Detailed description public domain (ClinicalTrials.gov)

The purpose of this study is to determine if it is safe to give Vitamin C by the vein at high doses to people with pancreatic cancer and if Vitamin C interferes with how well the chemotherapy works on cancer cells. This study will also look at how the body processes of Vitamin C. This study will also help researchers to learn more about long Vitamin C stays in the blood stream, and how rapidly it is used by the body.