Study to Assess Prevention of Oxaliplatin-induced Neurotoxicity Through Vitamin D Pathway
Condition: Neurotoxicity
MeSH terms: Neurotoxicity Syndromes
Intervention: Vitamin D3
Intervention description: Vitamin D3 will be administered at a dose of 2000 IU orally daily starting on day 1 of the first cycle of oxaliplatin. The vitamin will be continued at this dose and schedule for approximately 6 months if the patient is receiving oxaliplatin in the adjuvant setting and neither dosage nor interval has been modified for neurological toxicity. The duration of therapy if oxaliplatin is given for metastatic disease will vary. Nonetheless, the study vitamin will be continued using the same criteria as in the adjuvant setting.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: peripheral neuropathy; vitamin D status; oxaliplatin

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a histologic diagnosis of a malignant solid neoplasm involving the
             gastrointestinal tract not necessarily restricted to the colon, rectum, and esophagus,

          -  Will receive oxaliplatin-based chemotherapy for the first time (previous treatment
             with non-oxaliplatin-based chemotherapy does not preclude eligibility),

          -  Have disease of any stage and will be treated according to established standards,

          -  Have a performance status (ECOG) of 2 or less,

          -  Have intact organ function as determined by laboratory tests of the kidney, liver, and
             bone marrow deemed appropriate to receive cytotoxic chemotherapy,

          -  Are 18 years of age or older, and

          -  Have signed a consent and information form to participate in the study.

        Exclusion Criteria:

          -  Are pregnant (subjects of childbearing age will have a pregnancy test performed),

          -  Are taking calcitriol or have vitamin D levels that are >100 ng/dL,

          -  Are receiving medication for seizures, or

          -  Have pre-existing peripheral neuropathy grade >1.