Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

Phase 2

Recruiting

• Conditions: Neuropathic Pain
• Interventions: Dietary Supplement: Cholecalciferol Capsules; Drug: Ergocalciferol Capsules

• Registration Number: NCT05259527
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-28
• Study Start: 2022-12-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-21
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Cholecalciferol Capsules	Participants will receive standard-of-care advice to take over the counter vitamin D.
Vitamin D Replacement	Ergocalciferol Capsules	Participants will receive prescribed oral vitamin D2 to achieve a serum vitamin D level between 30 ng/mL to 50 ng/mL.

Primary Outcome Measures

Name	Time	Method
Self-reported neuropathic pain- sensory symptoms	12 Weeks	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.
Self-reported neuropathic pain- motor symptoms	12 weeks	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.
Self-reported neuropathic pain- autonomic symptoms	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Clinical diagnosis of peripheral neuropathy	12 Weeks	The number of participants with a clinical diagnosis of peripheral neuropathy. Chart review will be performed in order to determine whether an independent clinical diagnosis of peripheral neuropathy has been made for study participants.
Self-reported neuropathic pain	12 Weeks	The number of participants with self reported neuropathic pain using the PROMIS Scale v. 2.0 - Neuropathic Pain Quality 5a. This 5-item questionnaire asks respondents to indicate the extent to which they experienced symptoms of peripheral neuropathy in the past week on a scale from 1 ("not at all") to 5 ("very much"). The PROMIS Scale v. 2.0 - Neuropathic Pain Quality 5a will be administered at baseline and at 12 weeks in order to assess change in scores over time.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States