NCT02652715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

January 19, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2019

Completed
Last Updated

November 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

January 8, 2016

Last Update Submit

November 14, 2019

Conditions

Adult Nasal Type Extranodal NK/T-Cell LymphomaAdult T-Cell Leukemia/LymphomaAnaplastic Large Cell LymphomaAngioimmunoblastic T-Cell LymphomaB Lymphoblastic Leukemia/LymphomaBlastic Plasmacytoid Dendritic Cell NeoplasmBurkitt LeukemiaCentral Nervous System LymphomaChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaDiffuse Large B-Cell LymphomaEnteropathy-Associated T-Cell LymphomaExtranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid TissueGrade 1 Follicular LymphomaGrade 2 Follicular LymphomaGrade 3 Follicular LymphomaHepatosplenic T-Cell LymphomaLymphoplasmacytic LymphomaMantle Cell LymphomaMediastinal (Thymic) Large B-Cell LymphomaMycosis FungoidesNasal Type Extranodal NK/T-Cell LymphomaNodal Marginal Zone LymphomaPeripheral T-Cell Lymphoma, Not Otherwise SpecifiedPost-Transplant Lymphoproliferative DisorderPrimary Cutaneous Anaplastic Large Cell LymphomaPrimary Effusion LymphomaSezary SyndromeSplenic Marginal Zone LymphomaSubcutaneous Panniculitis-Like T-Cell LymphomaSystemic Anaplastic Large Cell LymphomaT Lymphoblastic Leukemia/LymphomaTransformed Recurrent Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Changes in n-3 levels after participants are no longer taking SH

    From 12 weeks to up to 16 weeks

  • Changes in stool microbiome after participants are no longer taking SH

    From 12 weeks to up to 16 weeks

  • Changes in stool microbiome after supplementation with SH, assessed by gene sequencing

    Baseline to up to 16 weeks

  • Incidence of adverse events graded according to the National Cancer Institute Common Toxicity Criteria version 4.0

    Up to 16 weeks

  • Patient compliance in stool sample collection

    Up to 16 weeks

Study Arms (1)

Basic science (Salvia hispanica seed)

EXPERIMENTAL

Patients receive Salvia hispanica seed PO QD for 12 weeks.

Other: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationDietary Supplement: Salvia hispanica Seed

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Basic science (Salvia hispanica seed)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Basic science (Salvia hispanica seed)
Questionnaire AdministrationOTHER

Ancillary studies

Basic science (Salvia hispanica seed)
Salvia hispanica SeedDIETARY_SUPPLEMENT

Given PO

Also known as: Chia, Chia Seed, SH Seed
Basic science (Salvia hispanica seed)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-CellPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphomaBlastic Plasmacytoid Dendritic Cell NeoplasmBurkitt LymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large B-Cell, DiffuseEnteropathy-Associated T-Cell LymphomaLymphoma, B-Cell, Marginal ZoneLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesLymphoma, T-CellLymphoma, Primary Cutaneous Anaplastic Large CellLymphoma, Primary EffusionSezary SyndromeSubcutaneous panniculitis-like T-cell lymphoma

Interventions

Salvia hispanica seed extract

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphadenopathyHistiocytic Disorders, MalignantHematologic NeoplasmsNeoplasms by SiteSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, T-Cell, Cutaneous

Study Officials

  • Thomas Witzig

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 12, 2016

Study Start

January 19, 2016

Primary Completion

December 21, 2018

Study Completion

November 12, 2019

Last Updated

November 15, 2019

Record last verified: 2019-01

Locations

US(1)