Study to Assess Prevention of Oxaliplatin-induced Neurotoxicity Through Vitamin D Pathway
Status:
Terminated
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
Many patients with cancer that are treated with a drug called oxaliplatin. This drug is used
with other drugs to treat cancer. The drug can cause problems with the nerves in the hands
and feet called peripheral neuropathy (a side effect of the drug). Peripheral neuropathy may
make the hands and feet feel like they are tingling, have a burning feeling, and can cause
pain. Almost all patients who receive oxaliplatin as part of their cancer treatment have
peripheral neuropathy. Patients who do have this side effect usually have to take a lower
dose of or stop taking the oxaliplatin even if the drug is helping their cancer.
So far there is not a lot of information about how to make this side effect better or help it
go away completely. There is some information that low levels of Vitamin D in the blood might
be linked to problems or diseases of the nervous system like multiple sclerosis or
Parkinson's Disease. It is even thought that Vitamin D may help protect the cells in the
nervous system. Because of this information, researchers want to see if giving patients
Vitamin D while they are receiving the drug oxaliplatin to see if it helps prevent the side
effect peripheral neuropathy.
Patients taking oxaliplatin who want to be in this study will take one Vitamin D capsule each
day while they take oxaliplatin. Being in this study will not affect how the patient's cancer
is treated. There are blood tests in the study to check Vitamin D levels and for a protein
called nerve growth factor (NGF). The study team will carefully monitor the patients for any
signs of oxaliplatin-related neurologic toxicity during the study.
Phase:
Phase 2
Details
Lead Sponsor:
Gerald Higa, PharmD.
Treatments:
Cholecalciferol Ergocalciferols Oxaliplatin Vitamin D Vitamins