Salvia Hispanica Seed in Reducing Risk of Disease Recurrence in Patients With Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT02652715|
Recruitment Status : Recruiting
First Posted : January 12, 2016
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration Dietary Supplement: Salvia hispanica Seed||Not Applicable|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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|
|Actual Study Start Date :||January 2016|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: Basic science (Salvia hispanica seed)
Patients receive Salvia hispanica seed PO QD for 12 weeks.
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Dietary Supplement: Salvia hispanica Seed
- Changes in improvement of n-3 serum alpha-linoleic acid levels [ Time Frame: Baseline to up to 16 weeks ]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).
- Changes in n-3 levels after participants are no longer taking SH [ Time Frame: From 12 weeks to up to 16 weeks ]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.
- Changes in stool microbiome after participants are no longer taking SH [ Time Frame: From 12 weeks to up to 16 weeks ]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.
- Changes in stool microbiome after supplementation with SH, assessed by gene sequencing [ Time Frame: Baseline to up to 16 weeks ]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.
- Incidence of adverse events graded according to the National Cancer Institute Common Toxicity Criteria version 4.0 [ Time Frame: Up to 16 weeks ]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.
- Patient compliance in stool sample collection [ Time Frame: Up to 16 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652715
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Referral Office 855-776-0015|
|Principal Investigator: Thomas E. Witzig|
|Principal Investigator:||Thomas Witzig||Mayo Clinic|