Clinical trial NCT02652715: Salvia Hispanica Seed in Reducing Risk of Disease Recurrence in Patients With Non-Hodgkin Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-01-12
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility 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

Primary outcomes:
measure: Changes in improvement of n-3 serum alpha-linoleic acid levels
timeFrame: Baseline to up to 16 weeks
Secondary outcomes:
measure: Changes in n-3 levels after participants are no longer taking SH
timeFrame: From 12 weeks to up to 16 weeks
measure: Changes in stool microbiome after participants are no longer taking SH
timeFrame: From 12 weeks to up to 16 weeks
measure: Changes in stool microbiome after supplementation with SH, assessed by gene sequencing
timeFrame: Baseline to up to 16 weeks
measure: Incidence of adverse events graded according to the National Cancer Institute Common Toxicity Criteria version 4.0
timeFrame: Up to 16 weeks
measure: Patient compliance in stool sample collection
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Thomas Witzig
role: PRINCIPAL_INVESTIGATOR
References: