Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

Last updated: October 30, 2025
Sponsor: Virginia Commonwealth University
Overall Status: Active - Recruiting

Phase

2

Condition

Neuropathy

Oral Facial Pain

Pain (Pediatric)

Treatment

Cholecalciferol Capsules

Ergocalciferol Capsules

Clinical Study ID

NCT05259527
MCC-21-18386
HM20023717
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of stage I-III cancer of any type, OR diagnosis of stage IV cancer beingtreated with curative intent

  • Receiving or scheduled to begin taxane-based chemotherapy at Virginia CommonwealthUniversity (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

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 calciumlevels <10.5 mg/dL may be enrolled in the observational arm.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Cholecalciferol Capsules
Phase: 2
Study Start date:
December 19, 2022
Estimated Completion Date:
March 31, 2030

Study 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.

Connect with a study center

  • Virginia Commonwealth University

    Richmond, Virginia 23286
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond 4781708, Virginia 6254928 23286
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.