Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Drug: Ergocalciferol Capsules
* Dietary Supplement: Cholecalciferol Capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of stage I-III cancer of any type, OR diagnosis of stage IV cancer being treated with curative intent Scheduled to begin taxane-based chemotherapy at Virginia Commonwealth University (VCU) Health Massey 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 Prior course of taxane-based chemotherapy Currently taking prescription Vitamin D (ergocalciferol) Inability to converse in English Pregnancy Chronic kidney disease (stage IV or greater) Known hyperparathyroidism Hypercalcemiacalcium levels >10.5 mg/dL Note: study participants with calcium levels <10.5 mg/dL may be enrolled in the observational arm.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D Replacement<br>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<br>* Vitamin D2 50,000IU by mouth once weekly for 8 weeks then once per month thereafter.<br>* Other names: Vitamin D2;|
| Active Comparator: Standard of Care<br>Participants will receive standard-of-care advice to take over the counter vitamin D. | Dietary Supplement: Cholecalciferol Capsules<br>* Vitamin D3 5,000IU by mouth daily<br>* Other names: Over the Counter Vitamin D3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported neuropathic pain | 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. | 12 Weeks | 
| Clinical diagnosis of peripheral neuropathy | 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. | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic pain, Neuropathy, Vitamin-D