Non-hodgkin Lymphoma
Conditions
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTMilled seed mix
Dietary intervention with or without seed mix
Sponsors
University of Belgrade
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
Single blind
Intervention model description
This study is a parallel, randomized, single blind, controlled, 5-months nutritional intervention, investigating health effects of dietary intake of milled mix of flax/sesame pumpkin seeds in sour milk, in patients with NHL undergoing chemotherapy. At the beginning of the study, all patients received nutritional counselling, where half of the study subjects are randomly assigned to a treatment arm with milled seed mix consumption, or control arm without seed mix. Treatment arm is provided with 450g of milled seed mix and instructed to consume 30g of the mix daily (18g flax seed, 6g pumpkin seeds, and 6 g sesame) in 180 mL of sour milk. Control arm is instructed to consume180 mL of sour milk.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in disease status | Baseline, 5 months, 1 year | Remission, stable disease or progression |
| Change in quality of life questionnaire scores | Baseline, 5 months, 1 year | Assessed by standardized questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in lipid profiles | Baseline, 5 months, 1 year | Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint |
| Changes in plasma fatty acids | Baseline, 5 months, 1 year | Changes in plasma fatty acids profiles from baseline to endpoint |
| Changes in body weight | Baseline, 5 months, 1 year | Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint |
| Changes in interleukin (IL)-6 | Baseline, 5 months, 1 year | Changes in interleukin (IL)-6 from baseline to endpoint |
| Changes in parameters of oxidative stress | Baseline, 5 months | Measures of activities of the following enzymes: SOD, catalase, glutathion peroxidase and glutation reductase |
| Changes in CRP | Baseline, 5 months, 1 year | Changes in CRP from baseline to endpoint |
| Changes in leukocyte count | Baseline, 5 months, 1 year | Measures of leukocyte count |
Countries
Serbia
Contacts
Primary ContactZorica Cvetkovic, MD PhD
Backup ContactSnjezana Petrovic, PhD
Outcome results
None listed