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Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

Recruiting
18 years and older
All
Phase 2

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Overview

This is a two-arm randomized clinical trial in which 80 participants with Vitamin D deficiency and scheduled to begin taxane-based chemotherapy will be randomized to either: 1) prescribed vitamin D replacement or 2) standard of care.

Description

This is a two-arm randomized clinical trial in which 80 participants with Vitamin D deficiency and scheduled to begin taxane-based chemotherapy will be randomized to either: 1) prescribed vitamin D replacement or 2) standard of care (advised to take over the counter (OTC) vitamin D).

All participants will have blood drawn for serum vitamin D analysis at Weeks 4, 8, 12, and 24 in order to document Vitamin D levels and titrate vitamin D dose (if needed in the treatment arm). Participants in both arms will complete self-report measures of neuropathic pain at baseline, Week 12, and Week 24.

Eligibility

Inclusion Criteria:

  • Diagnosis of stage I-III cancer of any type, OR diagnosis of stage IV cancer being treated with curative intent
  • Receiving or scheduled to begin taxane-based chemotherapy at Virginia Commonwealth University (VCU) Health Massey Comprehensive Cancer Center
  • Vitamin D serum level <20 ng/mL Note: study participants with Vitamin D serum level ≥20 ng/mL may be enrolled in the observational arm.

Exclusion Criteria:

  • Pre-existing diagnosis of neuropathy
  • Currently taking prescription Vitamin D (ergocalciferol)
  • Inability to converse in English
  • Pregnancy
  • Chronic kidney disease (stage IV or greater)
  • Known hyperparathyroidism
  • Hypercalcemia: Calcium levels >10.5 mg/dL Note: study participants with calcium levels <10.5 mg/dL may be enrolled in the observational arm.

Study details
    Neuropathic Pain

NCT05259527

Virginia Commonwealth University

7 November 2025

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