Salvia Hispanica Seed in Reducing Risk of Disease Recurrence in Patients With Non-Hodgkin Lymphoma

Descriptive Information
Brief Title † Salvia Hispanica Seed in Reducing Risk of Disease Recurrence in Patients With Non-Hodgkin Lymphoma
Official Title † A Pilot Feasibility Trial of the Tolerability of Oral Salvia Hispanica and Its Effect on Blood Fatty Acids and Stool Microbiome in Patients With Treated Non-Hodgkin Lymphoma
Brief 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.
Detailed 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 Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † Changes in improvement of n-3 serum alpha-linoleic acid levels
Secondary Outcome Measure † Changes in n-3 levels after participants are no longer taking SH
Condition † 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 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 Lymphoplasmacytic Lymphoma Mantle Cell Lymphoma Mediastinal (Thymic) Large B-Cell Lymphoma Mycosis Fungoides Nasal Type Extranodal NK/T-Cell Lymphoma Nodal Marginal Zone Lymphoma Peripheral T-Cell Lymphoma, Not Otherwise Specified Post-Transplant Lymphoproliferative Disorder 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
Intervention † OtherLaboratory Biomarker Analysis
Study Arms / Comparison Groups Basic science (Salvia hispanica seed) Patients receive Salvia hispanica seed PO QD for 12 weeks.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Other
Estimated Enrollment † 30
Start Date † January 2016
Completion Date May 2021
Primary Completion Date May 2021
Eligibility Criteria † Inclusion Criteria: - Have a diagnosis of any type of NHL and =
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT02652715
Organization ID LS1581
Secondary IDs †† NCI-2015-02149, 15-006720, LS1581, P30CA015083
Responsible Party Sponsor
Study Sponsor † Mayo Clinic
Collaborators †† National Cancer Institute (NCI)
Investigators † Principal Investigator: Thomas Witzig, Mayo Clinic
Information Provided By
Verification Date September 2016
First Received Date † January 8, 2016
Last Updated Date January 26, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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