Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Feb 17, 2022

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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.

Trial Officials