Status:
RECRUITING
Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 re...
Detailed 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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2030
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05259527
Start Date
December 19 2022
End Date
March 31 2030
Last Update
November 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23286