SuspendedPhase 2

Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

Stopped: Insufficient staffing

United States120 participantsStarted 2022-12-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Self-reported neuropathic pain- sensory symptoms

Timeframe: 12 Weeks

Self-reported neuropathic pain- motor symptoms

Timeframe: 12 weeks

Self-reported neuropathic pain- autonomic symptoms

Timeframe: 12 weeks

Trial details

NCT IDNCT05259527

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-03-31

View on ClinicalTrials.gov More Neuropathic Pain trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.