Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

NCT05259527 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: MCC-21-18386HM20023717
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 replacement or 2) standard of care.

Conditions

Neuropathic Pain

Keywords

Neuropathic pain; Neuropathy; Vitamin-D

Outcome Measures

Primary Outcomes (3)

• Self-reported neuropathic pain- sensory symptoms

  The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN (EORTC-QLQ-CIPN20) is a 20-item self-report questionnaire that includes a 9-item subscale assessing sensory symptoms of peripheral neuropathy. The questionnaire asks respondents to think about their past week and indicate to what extent they experienced symptoms of peripheral neuropathy: not at all; a little; quite a bit; or very much. The EORTC-QLQ-CIPN20 will be administered at baseline and at 12 weeks in order to assess change in scores over time.

  12 Weeks

• Self-reported neuropathic pain- motor symptoms

  The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN (EORTC-QLQ-CIPN20) is a 20-item self-report questionnaire that includes a 8-item subscale assessing motor symptoms of peripheral neuropathy. The questionnaire asks respondents to think about their past week and indicate to what extent they experienced symptoms of peripheral neuropathy: not at all; a little; quite a bit; or very much. The EORTC-QLQ-CIPN20 will be administered at baseline and at 12 weeks in order to assess change in scores over time.

  12 weeks

• Self-reported neuropathic pain- autonomic symptoms

  The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN (EORTC-QLQ-CIPN20) is a 20-item self-report questionnaire that includes a 3-item subscale assessing autonomic symptoms of peripheral neuropathy. The questionnaire asks respondents to think about their past week and indicate to what extent they experienced symptoms of peripheral neuropathy: not at all; a little; quite a bit; or very much. The EORTC-QLQ-CIPN20 will be administered at baseline and at 12 weeks in order to assess change in scores over time.

  12 weeks

Secondary Outcomes (2)

• Self-reported neuropathic pain

  12 Weeks

• Clinical diagnosis of peripheral neuropathy

  12 Weeks

Study Arms (3)

Vitamin D Replacement

EXPERIMENTAL

Participants will receive prescribed oral vitamin D2 to achieve a serum vitamin D level between 30 ng/mL to 50 ng/mL.

Drug: Ergocalciferol Capsules

Standard of Care

ACTIVE COMPARATOR

Participants will receive standard-of-care advice to take over the counter vitamin D.

Dietary Supplement: Cholecalciferol Capsules

Observation Arm

NO INTERVENTION

Observation only

Interventions

Ergocalciferol Capsules DRUG

Vitamin D2 50,000IU by mouth once weekly for 8 weeks then once per month thereafter.

Also known as: Vitamin D2

Vitamin D Replacement

Cholecalciferol Capsules DIETARY_SUPPLEMENT

Vitamin D3 5,000IU by mouth daily

Also known as: Over the Counter Vitamin D3

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23286, United States

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Ergocalciferols; Cholecalciferol

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Susan Hong, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Autumn Lanoye, PhD

CONTACT

804-828-4929; lanoyeam@vcu.edu

Susan Hong, MD

CONTACT

susan.hong@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: December 19, 2022
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)