ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 51 of 74 for:    Recruiting, Not yet recruiting, Available Studies | "Epstein-Barr Virus Infections"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02652715
Recruitment Status : Recruiting
First Posted : January 12, 2016
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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.

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

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.


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


Arm Intervention/treatment
Experimental: Basic science (Salvia hispanica seed)
Patients receive Salvia hispanica seed PO QD for 12 weeks.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Dietary Supplement: Salvia hispanica Seed
Given PO
Other Names:
  • Chia
  • Chia Seed
  • SH Seed




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Thomas E. Witzig         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thomas Witzig Mayo Clinic

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT02652715     History of Changes
Other Study ID Numbers: LS1581
NCI-2015-02149 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
15-006720
LS1581 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Epstein-Barr Virus Infections
Lymphoma
Leukemia
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, T-Cell
Lymphoma, Large B-Cell, Diffuse
Mycoses
Mycosis Fungoides
Sezary Syndrome
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Peripheral
Lymphoproliferative Disorders
Immunoblastic Lymphadenopathy
Lymphoma, Extranodal NK-T-Cell
Intestinal Diseases
Waldenstrom Macroglobulinemia
Lymphoma, Primary Effusion
Enteropathy-Associated T-Cell Lymphoma
Burkitt Lymphoma
Panniculitis
Lymphoma, Primary Cutaneous Anaplastic Large Cell