Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma

Non-hodgkin Lymphoma Clinical Trial

— Lymphoseed  

Official title:

Effects of Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03260231
• Other study ID #: 145/1
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2020
• Source: University of Belgrade
• Contact: Zorica Cvetkovic, MD PhD
• Phone: +381641302624
• Email: zokabora[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recent literature data suggest beneficial effects of dietary fats in patients with cancers, in particular polyunsaturated fatty acids (PUFAs). Milled mix of flax, sesame and pumpkin seeds provides a high amount of PUFAs and a desirable n-6/n-3 PUFAs ratio.

Description:

Cancers are characterized by inflammation and alternations in lipid and fatty acid metabolism. Patients with non-Hodgkin lymphoma have impaired fatty acid profiles, low level of PUFAs, and high n-6/n-3 PUFAs ratio. Moreover, these changes are related to clinical outcome.

Flax seeds, sesame and pumpkin seeds are rich sources of PUFAs. Dietary intake of milled mix of these seeds has been shown to decrease inflammation and improve PUFAs status in patients on hemodialysis and to decrease breast cancer risk.

The study design is single-blind, controlled, randomized nutritional intervention. The participants are randomly assigned into intervention and control group before starting chemotherapy. All patients receive nutritional counseling to achieve a daily energy and protein intake according to recommended dietary allowances, with (intervention) or without (control) of milled seed mix.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed Non-Hodgkin lymphoma

• Patients able to understand requirements of the study and provide written informed consent

Exclusion Criteria:

• Previous radio- or chemotherapy

• Other serious chronic diseases

• Statin therapy

• Presence of allergy on any seeds

• Use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3 months prior to study

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-hodgkin Lymphoma

Intervention

Dietary Supplement:
• Milled seed mix
Dietary intervention with or without seed mix

Locations

Country	Name	City	State
Serbia	Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

References & Publications (3)

Cvetkovic Z, Miloševic M, Cvetkovic B, Masnikosa R, Arsic A, Petrovic S, Vucic V. Plasma phospholipid changes are associated with response to chemotherapy in non-Hodgkin lymphoma patients. Leuk Res. 2017 Mar;54:39-46. doi: 10.1016/j.leukres.2017.01.004. Epub 2017 Jan 5. — View Citation

Cvetkovic Z, Vucic V, Cvetkovic B, Petrovic M, Ristic-Medic D, Tepsic J, Glibetic M. Abnormal fatty acid distribution of the serum phospholipids of patients with non-Hodgkin lymphoma. Ann Hematol. 2010 Aug;89(8):775-82. doi: 10.1007/s00277-010-0904-6. Epub 2010 Feb 3. — View Citation

Ristic-Medic D, Perunicic-Pekovic G, Rasic-Milutinovic Z, Takic M, Popovic T, Arsic A, Glibetic M. Effects of dietary milled seed mixture on fatty acid status and inflammatory markers in patients on hemodialysis. ScientificWorldJournal. 2014 Jan 22;2014:563576. doi: 10.1155/2014/563576. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disease status	Remission, stable disease or progression	Baseline, 5 months, 1 year
Primary	Change in quality of life questionnaire scores	Assessed by standardized questionnaires	Baseline, 5 months, 1 year
Secondary	Changes in body weight	Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint	Baseline, 5 months, 1 year
Secondary	Changes in leukocyte count	Measures of leukocyte count	Baseline, 5 months, 1 year
Secondary	Changes in lipid profiles	Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint	Baseline, 5 months, 1 year
Secondary	Changes in plasma fatty acids	Changes in plasma fatty acids profiles from baseline to endpoint	Baseline, 5 months, 1 year
Secondary	Changes in CRP	Changes in CRP from baseline to endpoint	Baseline, 5 months, 1 year
Secondary	Changes in interleukin (IL)-6	Changes in interleukin (IL)-6 from baseline to endpoint	Baseline, 5 months, 1 year
Secondary	Changes in parameters of oxidative stress	Measures of activities of the following enzymes: SOD, catalase, glutathion peroxidase and glutation reductase	Baseline, 5 months