Trials / Completed
CompletedNCT02652715
Salvia Hispanica Seed in Reducing Risk of Disease Recurrence in Patients With Non-Hodgkin Lymphoma
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
| OTHER | Questionnaire Administration | Ancillary studies |
| DIETARY_SUPPLEMENT | Salvia hispanica Seed | Given PO |
Timeline
- Start date
- 2016-01-19
- Primary completion
- 2018-12-21
- Completion
- 2019-11-12
- First posted
- 2016-01-12
- Last updated
- 2019-11-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02652715. Inclusion in this directory is not an endorsement.