NCT06596122

Vitamin D Supplementation in Breast Cancer Patients

The Effect of Vitamin D Supplementation in Breast Cancer Patients Receiving Taxane-based Chemotherapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Abdelrahman Mahmoud · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

It is a randomized clinical trial aimed at exploring the neuroprotective effect of vitamin D3 (Cholecalciferol) supplementation in conjunction with paclitaxel-based chemotherapy among breast cancer patients with vitamin D insufficiency or deficiency.

Detailed description

This study is a two-arm randomized controlled trial with 132 participants, evenly randomized into an intervention group and a control group. Both groups are scheduled to receive Adriamycin-Cyclophosphamide followed by paclitaxel (AC-T) chemotherapy protocol. The intervention group will undergo paclitaxel-based chemotherapy, along with vitamin D replacement therapy. Conversely, the control group will follow the AC-T protocol without the addition of vitamin D replacement therapy.

Conditions

• Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Vitamin D (Cholecalciferol )	In conjunction with the AC-T chemotherapy protocol, individuals in the intervention group who have a vitamin D deficiency will receive an oral loading dose of 50,000 IU weekly for eight weeks. Subsequently, they will be given 100,000 IU monthly until the completion of their chemotherapy treatment.

Timeline

• Start date: 2024-10-15
• Primary completion: 2026-11-30
• Completion: 2026-12-30
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Egypt