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

Completed · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT02652715
Run by: Mayo Clinic
People needed: 29
Starts: 2016-01-19
Expected to finish: 2019-11-12
Last updated by the study team: 2019-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have a diagnosis of any type of NHL and =< 5 years from the last treatment
In remission (complete remission [CR], partial remission [PR], or stable disease based on clinical, not necessarily radiologic, assessment) and currently being observed and with no current cytotoxic chemotherapy planned; patients may be on rituximab maintenance
No international travel planned during the next 4 months
Able to eat a full range of solid food and liquids and tolerate seeds/nuts
Maintain a consistent general diet without significant variation
Able to deliver four fresh (within 24 hours) stool samples to Mayo Clinic Rochester over a four month period
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Provide informed written consent
Able to recollect dietary intake for the prior 24 hours in order to complete a one-day food record with assistance from a dietician at each study visit
Willing to complete the food frequency questionnaire (FFQ) at baseline and at 16 week visits with assistance from a dietician
Willing to be seen at baseline, 6 weeks, 12 weeks, and 16 weeks for the study time points
Willing to provide blood and stool samples at baseline and study time points for correlative research purposes

You may not qualify if…

Cannot eat normal table food by mouth; NOTE: patients with any form of feeding tube or a swallowing disorder are not eligible
Have taken fish oil, another dedicated n-3 supplement, or SH seed from another source within the last 28 days; patients on multivitamins that contain n-3 are eligible
Co-morbid systemic illnesses such as active infection or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens; NOTE: patients with significant gut malabsorptive conditions (such as inflammatory bowel disease or others at the discretion of the investigator) will be excluded
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Receiving any other investigational agent that would be considered as a treatment for the lymphoma; NOTE: rituximab maintenance and patients participating on Mayo Clinic vitamin D study are allowed
Active other malignancy requiring treatment that would interfere with the assessments of this study
Major surgery other than diagnostic surgery =< 4 weeks prior to registration
On prophylactic antibiotics, such as trimethoprim-sulfamethoxazole for pneumocystis prophylaxis or post-transplant penicillin prophylaxis
Have taken antibiotics =< 7 days prior to registration

Where it is running

Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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