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

  • STATUS
    Recruiting
  • participants needed
    713
  • sponsor
    Mayo Clinic
Updated on 6 December 2021
cancer
calcium
cyclophosphamide
chronic lymphocytic leukemia
lymphoma
hodgkin's disease
rituximab
prednisone
treatment regimen
doxorubicin
burkitt's lymphoma
anthracyclines
diffuse large b-cell lymphoma
b-cell lymphoma
mantle cell lymphoma
cluster of differentiation
immunoglobulin
enteropathy
panniculitis
t-cell lymphoma
peripheral t-cell lymphoma
angioimmunoblastic t-cell lymphoma
anaplastic large cell lymphoma
large cell lymphoma
hepatosplenic t-cell lymphoma
cyclin d1
extranodal nk/t-cell lymphoma, nasal type
intestinal t-cell lymphoma
extranodal nk/t-cell lymphoma

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.

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.

Details
Condition Primary cutaneous anaplastic large cell lymphoma, Angiocentric T-cell lymphoma, Diffuse Large B-Cell Lymphoma, Peripheral T-Cell Lymphoma, cutaneous T-cell lymphoma, anaplastic large cell lymphoma, Enteropathy-Associated T-Cell Lymphoma, Chronic Lymphocytic Leukemia, T-Cell Lymphoma, Angioimmunoblastic Lymphadenopathy, Lymphocytic Leukemia, Chronic, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Refractory Anaplastic Large Cell Lymphoma, Subcutaneous Panniculitis-Like T-Cell Lymphoma, Subcutaneous Panniculitis Like T Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, intestinal t-cell lymphoma, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma, b-cell small lymphocytic lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma
Treatment laboratory biomarker analysis, Cholecalciferol, Cholecalciferol
Clinical Study IdentifierNCT01787409
SponsorMayo Clinic
Last Modified on6 December 2021

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