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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Mayo Clinic

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: January 8, 2016
Date Started: January 2016
Date Completion: May 2021
Last Updated: January 26, 2017
Last Verified: September 2016