Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms

  • 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
  • Burkitt Lymphoma
  • 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
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Primary Cutaneous Anaplastic Large Cell
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral
  • Lymphoplasmacytic Lymphoma
  • Lymphoproliferative Disorders
  • Mantle Cell Lymphoma
  • Mediastinal (Thymic) Large B-Cell Lymphoma
  • Mycoses
  • Mycosis Fungoides
  • Nasal Type Extranodal NK/T-Cell Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Panniculitis
  • Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Post-Transplant Lymphoproliferative Disorder
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • 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
  • Waldenstrom Macroglobulinemia

NCT number NCT02652715
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase N/A
Start date January 19, 2016
Completion date November 12, 2019

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT01804686 - A Long-term Extension Study of PCI-32765 (Ibrutinib) Phase 3
Recruiting NCT05976763 - Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma Phase 3
Recruiting NCT03676504 - Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR Phase 1/Phase 2
Recruiting NCT05365659 - IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas Phase 1
Recruiting NCT05471843 - Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma Phase 1/Phase 2
Recruiting NCT05076097 - A Study of OLR in First-line Treatment of Mantle Cell Lymphoma Phase 2
Active, not recruiting NCT03891355 - Carfilzomib + Lenalidomide and Dexamethasone for BTK Inhibitors Relapsed-refractory or Intolerant MCL Phase 2
Active, not recruiting NCT04082936 - A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma Phase 1/Phase 2
Recruiting NCT04883437 - Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas Phase 2
Terminated NCT03585725 - A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma Early Phase 1
Recruiting NCT02892695 - PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma Phase 1/Phase 2
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Completed NCT01665768 - Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma Phase 2
Completed NCT01437709 - Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant Phase 2
Completed NCT00963534 - Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma. Phase 1/Phase 2
Completed NCT00921414 - Mantel Cell Lymphoma Efficacy of Rituximab Maintenance Phase 3
Withdrawn NCT00541424 - Combined CT Colonography and PET Imaging in Mantle Cell Lymphoma N/A
Completed NCT01456351 - Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab Phase 3
Completed NCT01851551 - Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL Phase 1/Phase 2
Completed NCT03295240 - The Study of Bendamustine, Rituximab, Ibrutinib, and Venetoclax in Relapsed, Refractory Mantle Cell Lymphoma Early Phase 1