NCT01787409

Cholecalciferol in Improving Survival in Patients With Newly Diagnosed Cancer With Vitamin D Insufficiency

Effect of Vitamin D Replacement on Tumor Response and Survival Parameters for Vitamin D Insufficient Patients With Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 565 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This partially randomized clinical trial studies cholecalciferol in improving survival in patients with newly diagnosed cancer with vitamin D insufficiency. Vitamin D replacement may improve tumor response and survival and delay time to treatment in patients with cancer who are vitamin D insufficient.

Detailed description

PRIMARY OBJECTIVES: I. To determine if vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated diffuse large B-cell lymphoma (DLBCL) can improve event free survival at 12 months to be equivalent to that of a control population of vitamin D sufficient patients. (Study I) II. To assess the percentage of patients requiring treatment with conventional therapy at 36 in months in vitamin D insufficient patients with early stage chronic lymphocytic leukemia (CLL) being managed with observation who undergo vitamin D replacement. (Study II) SECONDARY OBJECTIVES: I. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated DLBCL on overall survival. (Study I) II. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated DLBCL on event free survival. (Study I) III. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated T cell lymphoma on event free and overall survival. (Study I) IV. To assess the effect of vitamin D replacement in vitamin D insufficient CLL patients on Bio-r response rate and overall response rate. (Study II) V. To assess time to treatment and overall survival in vitamin D insufficient CLL patients who received vitamin D replacement. (Study II) TERTIARY OBJECTIVES: I. To study immune effector cells (lymphocytes, monocytes), serum cytokines, and tumor cells from vitamin D deficient and sufficient patients to learn the effects of vitamin D on both tumor cells and the patient's immune system. (Study I-II) OUTLINE: Vitamin D sufficient patients receive no intervention. Vitamin D insufficient patients receive cholecalciferol orally (PO) once weekly for 12 weeks and then once monthly for a total of 36 months. After completion of study treatment, patients are followed up for 2 years.

Conditions

• Aggressive Non-Hodgkin Lymphoma
• Anaplastic Large Cell Lymphoma
• Angioimmunoblastic T-Cell Lymphoma
• Chronic Lymphocytic Leukemia
• Diffuse Large B-Cell Lymphoma
• Enteropathy-Associated T-Cell Lymphoma
• Hepatosplenic T-Cell Lymphoma
• Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
• Mediastinal (Thymic) Large B-Cell Lymphoma
• Nasal Type Extranodal NK/T-Cell Lymphoma
• Peripheral T-Cell Lymphoma, Not Otherwise Specified
• Primary Cutaneous Anaplastic Large Cell Lymphoma
• Refractory Anaplastic Large Cell Lymphoma
• Small Lymphocytic Lymphoma
• Subcutaneous Panniculitis-Like T-Cell Lymphoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cholecalciferol	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2013-03-06
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2013-02-08
• Last updated: 2025-12-30

Locations

5 sites across 1 country: United States