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Study to Assess Prevention of Oxaliplatin-induced Neurotoxicity Through Vitamin D Pathway

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by West Virginia University
Sponsor:
Information provided by (Responsible Party):
Gerald Higa, PharmD., West Virginia University
ClinicalTrials.gov Identifier:
NCT01499940
First received: October 18, 2011
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Neurotoxicity
Drug: Vitamin D3
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase II Study to Assess Prevention of Oxaliplatin-induced Neurotoxicity Through the Vitamin D Pathway

Resource links provided by NLM:


Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • Incidence of peripheral neurotoxic reactions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    NCI CTCAE Version 4.0


Secondary Outcome Measures:
  • Determine whether a correlation exists between serum Vitamin D levels and incident neurotoxicity [ Time Frame: Once a month for 12 months ] [ Designated as safety issue: No ]
    Recently recommended definitions of vitamin D status according to the Endocrine Society will be correlated with NCI (CTCAE) version 4.0 definitions of neurotoxicity.


Estimated Enrollment: 45
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Vitamin D3
    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.
    Other Name: Cholecalciferol
Detailed Description:

Oxaliplatin is used most frequently in patients with metastatic and early-stage colorectal cancers. It has been found that in the adjuvant setting, Oxaliplatin improves both disease free and overall survival. Despite these results, the use of Oxaliplatin is limited by the sensory neuropathy or numbness and tingling, that occurs in 80% -90% of patients. Some of these patients will develop irreversible and debilitating neuropathy, in which the drug may no longer be used to treat their cancer.

It is expected that this proposed study will provide new information for the role of Vitamin D in the pathogenesis of Oxaliplatin-induced neurotoxicity. The dynamic effects of Vitamin D on calcium and nerve growth factor plus the now recognized state of subclinical Vitamin D deficiency are compelling pieces of evidence that indicate this hormone may be in a pivotal position in the multifactorial pathogenesis of neurotoxic reactions induced by Oxaliplatin. The specific aim of the study is to determine the neuroprotective effects of Vitamin D.

Patients will receive Oxaliplatin at a dose of 80 mg/m2 at a physician determined frequency appropriate for the underlying malignancy, which can be any histological diagnosis of a malignant solid neoplasm involving the GI tract not restricted to the colon, rectum and esophagus. Blood will be collected to monitor the level of Vitamin D and nerve growth factor (NGF) at specific time points. Vitamin D levels will be checked once a month and NGF levels will be checked bi-weekly. These blood samples will be collected at the same time of the patients routine blood draws. Patients will take one capsule containing 2000 IUs of Vitamin D3 daily, beginning up to 7 days prior to the first dose of Oxaliplatin. Vitamin D3 will be provided to patients as long as they remain on the study.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499940

Contacts
Contact: Angela Rishel, RN (304) 293-2149 arishel@hsc.wvu.edu
Contact: Gerald Higa, PharmD (304) 293-1461 ghiga@hsc.wvu.edu

Locations
United States, West Virginia
West Virginia University Hospitals Mary Babb Randolph Cancer Center Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Angela Rishel, RN    304-293-2149    arishel@hsc.wvu.edu   
Contact: Sylvia McEwuen, RN    (304) 293-1683    smcewuen@hsc.wvu.edu   
Sub-Investigator: Sobha Kurian, MD         
Sub-Investigator: Miklos Auber, MD         
Sub-Investigator: Quoc Sean Truong, MD         
Sub-Investigator: Jason Hicks         
Sub-Investigator: Chris Isabella         
Sub-Investigator: Gerry Hobbs, PhD         
Sponsors and Collaborators
Gerald Higa, PharmD.
Investigators
Principal Investigator: Gerald Higa, PharmD West Virginia University
  More Information

Publications:
Responsible Party: Gerald Higa, PharmD., Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT01499940     History of Changes
Other Study ID Numbers: WVU 11011
Study First Received: October 18, 2011
Last Updated: December 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University:
peripheral neuropathy
vitamin D status
oxaliplatin

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Chemically-Induced Disorders
Nervous System Diseases
Poisoning
Cholecalciferol
Ergocalciferols
Oxaliplatin
Vitamin D
Vitamins
Antineoplastic Agents
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014