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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-02149 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 15-006720 | |||
| LS1581 | Other Identifier | Mayo Clinic | |
| P30CA015083 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic science (Salvia hispanica seed) | Experimental | Patients receive Salvia hispanica seed PO QD for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in improvement of n-3 serum alpha-linoleic acid levels | n-3 level will be evaluated as a continuous measure, where the median and range will be summarized at each time point. Changes across time will be evaluated graphically. Changes from baseline will be quantitatively summarized and will be evaluated using paired sample methods (paired sample t-test). | Baseline to up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in n-3 levels after participants are no longer taking SH | The evaluation of whether changes in n-3 levels persist or resolve after participants are no longer taking SH will be assessed using a paired t test comparing the mean values at 12 weeks to the mean values at 16 weeks. Changes from week 12 to week 16 will also be calculated and the mean magnitude of change will be explored. | From 12 weeks to up to 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Witzig | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Quality-of-Life Assessment |
| Other |
Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Salvia hispanica Seed | Dietary Supplement | Given PO |
|
|
| Changes in stool microbiome after participants are no longer taking SH | The evaluation of whether changes in stool microbiome persist or resolve after participants are no longer taking SH will be assessed using a paired t test comparing the mean values at 12 weeks to the mean values at 16 weeks. Changes from week 12 to week 16 will also be calculated and the mean magnitude of change will be explored. | From 12 weeks to up to 16 weeks |
| Changes in stool microbiome after supplementation with SH, assessed by gene sequencing | Patient's initial sample will provide a control to assess alterations in stool deoxyribonucleic acid (DNA) (reflecting stool bacterial populations) after supplementation with SH. Measurable change will be assessed based on standardized methods. | Baseline to up to 16 weeks |
| Incidence of adverse events graded according to the National Cancer Institute Common Toxicity Criteria version 4.0 | Safety and tolerability will be assessed utilizing stool and symptom diaries. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The relationship of the adverse event(s) to the study treatment will be taken into consideration. In addition, tolerability will be further assessed by evaluating the number of doses missed due to adverse events. Reasons for missed doses will be summarized. | Up to 16 weeks |
| Patient compliance in stool sample collection | Patient compliance in stool sample collection will be assessed by evaluating the percentage of patients who provide a sample at each time point. The percentage of patients who provide samples for 0, 1, 2, 3, or all 4 time points will be calculated to determine the feasibility of requesting multiple samples on future studies. | Up to 16 weeks |
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D007119 | Immunoblastic Lymphadenopathy |
| D008223 | Lymphoma |
| D000099067 | Blastic Plasmacytoid Dendritic Cell Neoplasm |
| D002051 | Burkitt Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D058527 | Enteropathy-Associated T-Cell Lymphoma |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D009182 | Mycosis Fungoides |
| D016399 | Lymphoma, T-Cell |
| D054446 | Lymphoma, Primary Cutaneous Anaplastic Large Cell |
| D054685 | Lymphoma, Primary Effusion |
| D012751 | Sezary Syndrome |
| C537503 | Subcutaneous panniculitis-like T-cell lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072281 | Lymphadenopathy |
| D015620 | Histiocytic Disorders, Malignant |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016410 | Lymphoma, T-Cell, Cutaneous |
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| ID | Term |
|---|---|
| C000715327 | Salvia hispanica seed extract |
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