Neuropathic Pain
Conditions
Keywords
Neuropathic pain, Neuropathy, Vitamin-D
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.
Interventions
Vitamin D2 50,000IU by mouth once weekly for 8 weeks then once per month thereafter.
DIETARY_SUPPLEMENTCholecalciferol Capsules
Vitamin D3 5,000IU by mouth daily
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSusan Hong, MD
Virginia Commonwealth University
Outcome results
None listed