Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259527
• Other study ID #: MCC-21-18386
• Secondary ID: HM20023717
• Status: Recruiting
• Phase: Phase 2
• Start date: December 19, 2022
• Est. completion date: March 31, 2027

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: Autumn Lanoye, PhD
• Phone: 804-828-4929
• Email: lanoyeam[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Ergocalciferol Capsules
Vitamin D2 50,000IU by mouth once weekly for 8 weeks then once per month thereafter.

Dietary Supplement:
• Cholecalciferol Capsules
Vitamin D3 5,000IU by mouth daily

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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