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Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

Primary Purpose

Neuropathic Pain

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ergocalciferol Capsules
Cholecalciferol Capsules
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neuropathic Pain focused on measuring Neuropathic pain, Neuropathy, Vitamin-D

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of stage I-III cancer of any type
  • Scheduled to begin taxane-based chemotherapy at Virginia Commonwealth University (VCU) Health Massey Cancer Center
  • Vitamin D serum level <20 ng/mL

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
  • Hypercalcemia

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitamin D Replacement

Standard of Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 17, 2022
Last Updated
March 10, 2023
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT05259527
Brief Title
Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy
Official Title
Impact of Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Neuropathic pain, Neuropathy, Vitamin-D

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D Replacement
Arm Type
Experimental
Arm Description
Participants will receive prescribed oral vitamin D2 to achieve a serum vitamin D level between 30 ng/mL to 50 ng/mL.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Participants will receive standard-of-care advice to take over the counter vitamin D.
Intervention Type
Drug
Intervention Name(s)
Ergocalciferol Capsules
Other Intervention Name(s)
Vitamin D2
Intervention Description
Vitamin D2 50,000IU by mouth once weekly for 8 weeks then once per month thereafter.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol Capsules
Other Intervention Name(s)
Over the Counter Vitamin D3
Intervention Description
Vitamin D3 5,000IU by mouth daily
Primary Outcome Measure Information:
Title
Self-reported neuropathic pain- sensory symptoms
Description
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.
Time Frame
12 Weeks
Title
Self-reported neuropathic pain- motor symptoms
Description
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.
Time Frame
12 weeks
Title
Self-reported neuropathic pain- autonomic symptoms
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Self-reported neuropathic pain
Description
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.
Time Frame
12 Weeks
Title
Clinical diagnosis of peripheral neuropathy
Description
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.
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 Hypercalcemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Autumn Lanoye, PhD
Phone
804-828-4929
Email
lanoyeam@vcu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Hong, MD
Email
susan.hong@vcuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Hong, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23286
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Autumn Lanoye, PhD
Phone
804-828-4929
Email
autumn.lanoye@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Susan Hong, MD
Email
susan.hong@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Susan Hong, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to make individual participant data (IPD) available to other researchers at this time.

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Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

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