Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

Virginia Commonwealth University (VCU)

Status and phase: Enrolling; Phase 2

Conditions: Neuropathic Pain

Treatments: Drug: Ergocalciferol Capsules; Dietary Supplement: Cholecalciferol Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT05259527

HM20023717 (Other Identifier)

MCC-21-18386

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Vitamin D Replacement

Experimental group

Description:

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

Treatment:

Drug: Ergocalciferol Capsules

Standard of Care

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Cholecalciferol Capsules

Observation Arm

No Intervention group

Description:

Observation only