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

NCT01499940 | Terminated Phase 2 Results DMC

• 1 other identifier: WVU 11011
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurotoxicity

Keywords

peripheral neuropathy; vitamin D status; oxaliplatin

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Peripheral Neurotoxic Reactions

  NCI CTCAE Version 4.0

  Up to 12 months

Study Arms (1)

Vitamin D3 2000 IU/day

EXPERIMENTAL

Vitamin D3 2000 IU/day on day of 1st cycle of oxaliplatin; continue as long as patient treated with oxaliplatin and remains on study

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

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.

Also known as: Cholecalciferol

Vitamin D3 2000 IU/day

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gerald Higa, PharmD.: lead

Study Sites (1)

West Virginia University Hospitals Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

Related Publications (5)

• Kim JS, Ryu SY, Yun I, Kim WJ, Lee KS, Park JW, Kim YI. 1alpha,25-Dihydroxyvitamin D(3) Protects Dopaminergic Neurons in Rodent Models of Parkinson's Disease through Inhibition of Microglial Activation. J Clin Neurol. 2006 Dec;2(4):252-7. doi: 10.3988/jcn.2006.2.4.252. Epub 2006 Dec 20.

  PMID: 20396528 BACKGROUND

• Wang JY, Wu JN, Cherng TL, Hoffer BJ, Chen HH, Borlongan CV, Wang Y. Vitamin D(3) attenuates 6-hydroxydopamine-induced neurotoxicity in rats. Brain Res. 2001 Jun 15;904(1):67-75. doi: 10.1016/s0006-8993(01)02450-7.

  PMID: 11516412 BACKGROUND

• Bischoff-Ferrari HA, Giovannucci E, Willett WC, Dietrich T, Dawson-Hughes B. Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes. Am J Clin Nutr. 2006 Jul;84(1):18-28. doi: 10.1093/ajcn/84.1.18.

  PMID: 16825677 BACKGROUND

• Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

  PMID: 17634462 BACKGROUND

• Heaney RP. Functional indices of vitamin D status and ramifications of vitamin D deficiency. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1706S-9S. doi: 10.1093/ajcn/80.6.1706S.

  PMID: 15585791 BACKGROUND

MeSH Terms

Conditions

Neurotoxicity Syndromes; Peripheral Nervous System Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Gerald Higa, PharmD
• Organization: West Virginia Universtiy

ghiga@hsc.wvu.edu

(304) 293-1461

Study Officials

• Gerald Higa, PharmD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: December 26, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 10, 2021
• Results First Posted: September 5, 2021

Record last verified: 2021-11

Locations

US (1)