Vitamin D replacement to reduce taxane-related nerve pain
Impact of Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy
This trial will test whether giving vitamin D to people with low vitamin D who are starting taxane chemotherapy reduces nerve pain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT05259527 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 2 trial will enroll 80 participants with vitamin D deficiency (<20 ng/mL) who are initiating taxane-based chemotherapy at VCU. Participants will be randomized to prescribed vitamin D replacement (with dosing titrated based on blood levels) or to standard of care (advised to take over-the-counter vitamin D). Blood will be drawn at Weeks 4, 8, 12, and 24 to document serum vitamin D and adjust dosing in the treatment arm, and self-reported neuropathic pain measures will be collected at baseline, Week 12, and Week 24. The trial tests whether correcting vitamin D deficiency reduces the rates or severity of taxane-induced neuropathy.
Who should consider this trial
Good fit: Ideal candidates are adults with stage I–III cancer (or stage IV treated with curative intent) who have vitamin D levels under 20 ng/mL and are scheduled to begin taxane chemotherapy at VCU.
Not a fit: Patients with pre-existing neuropathy, those already taking prescription vitamin D, people with advanced chronic kidney disease or known hyperparathyroidism, pregnant people, or those unable to attend VCU visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a low-cost way to lower the chance or severity of nerve pain from taxane chemotherapy.
How similar studies have performed: Some small studies suggest vitamin D can improve peripheral neuropathy symptoms, but using vitamin D specifically to prevent taxane-induced neuropathy is largely untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Susan Hong, MD — Virginia Commonwealth University
- Study coordinator: Autumn Lanoye, PhD
- Email: lanoyeam@vcu.edu
- Phone: 804-828-4929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.