Impact of Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy
Virginia Commonwealth University
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.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 kidne…
Interventions
- DrugErgocalciferol Capsules
Vitamin D2 50,000IU by mouth once weekly for 8 weeks then once per month thereafter.
- Dietary SupplementCholecalciferol Capsules
Vitamin D3 5,000IU by mouth daily
Location
- Virginia Commonwealth UniversityRichmond, Virginia