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Clinical Trial Summary

This pilot clinical trial studies Salvia hispanica seed in reducing the risk of returning disease (recurrence) in patients with non-Hodgkin lymphoma. Functional foods, such as Salvia hispanica seed, has health benefits beyond basic nutrition by reducing disease risk and promoting optimal health. Salvia hispanica seed contains essential poly-unsaturated fatty acids, including omega 3 alpha linoleic acid and omega 6 linoleic acid; it also contains high levels of antioxidants and dietary soluble fiber. Salvia hispanica seed may raise omega-3 levels in the blood and/or change the bacterial populations that live in the digestive system and reduce the risk of disease recurrence in patients with non-Hodgkin lymphoma.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. Assess if dietary supplementation with the functional food Salvia hispanica (SH) seed improves serum omega-3 (n-3) fatty acids (FA) levels in patients with non-Hodgkin lymphoma (NHL) who have recently completed chemotherapy.

SECONDARY OBJECTIVES:

I. Evaluate the safety and tolerability of patients taking 16 grams (g) (approximately 1 United States [US] tablespoon) of SH per day.

II. Evaluate the compliance of stool sample collection in lymphoma patients who have completed therapy and are in remission.

III. Evaluate if SH can exert measurable changes of the stool microbiome. IV. Evaluate if changes in n-3 levels and stool microbiome persist or resolve after participants are no longer taking SH.

OUTLINE:

Patients receive Salvia hispanica seed orally (PO) once daily (QD) for 12 weeks.

After completion of study, patients are followed up at 4 weeks. ;


Study Design


Related Conditions & MeSH terms

  • Adult Nasal Type Extranodal NK/T-Cell Lymphoma
  • Adult T-Cell Leukemia/Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-Cell Lymphoma
  • B Lymphoblastic Leukemia/Lymphoma
  • Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Burkitt Leukemia
  • Burkitt Lymphoma
  • Central Nervous System Lymphoma
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Enteropathy-Associated T-Cell Lymphoma
  • Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • Grade 1 Follicular Lymphoma
  • Grade 2 Follicular Lymphoma
  • Grade 3 Follicular Lymphoma
  • Hepatosplenic T-Cell Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Primary Cutaneous Anaplastic Large Cell
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral
  • Lymphoplasmacytic Lymphoma
  • Lymphoproliferative Disorders
  • Mantle Cell Lymphoma
  • Mediastinal (Thymic) Large B-Cell Lymphoma
  • Mycoses
  • Mycosis Fungoides
  • Nasal Type Extranodal NK/T-Cell Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Panniculitis
  • Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Post-Transplant Lymphoproliferative Disorder
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Primary Cutaneous Anaplastic Large Cell Lymphoma
  • Primary Effusion Lymphoma
  • Sezary Syndrome
  • Splenic Marginal Zone Lymphoma
  • Subcutaneous Panniculitis-Like T-Cell Lymphoma
  • Systemic Anaplastic Large Cell Lymphoma
  • T Lymphoblastic Leukemia/Lymphoma
  • Transformed Recurrent Non-Hodgkin Lymphoma
  • Waldenstrom Macroglobulinemia

NCT number NCT02652715
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase N/A
Start date January 19, 2016
Completion date November 12, 2019

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