Mantle Cell Lymphoma Clinical Trial
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
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.
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.
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