Impact of Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy
Who is this study for? Patients with Neuropathic Pain
Status: Recruiting
Location: See location...
Intervention Type: Drug, Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Autumn Lanoye, PhD
lanoyeam@vcu.edu
804-828-4929
Backup
Susan Hong, MD
susan.hong@vcuhealth.org
Time Frame
Start Date: 2022-12-19
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 120
Treatments
Experimental: Vitamin D Replacement
Participants will receive prescribed oral vitamin D2 to achieve a serum vitamin D level between 30 ng/mL to 50 ng/mL.
Active_comparator: Standard of Care
Participants will receive standard-of-care advice to take over the counter vitamin D.
No_intervention: Observation Arm
Observation only
Related Therapeutic Areas
Sponsors
Leads: Virginia Commonwealth University