Clinical trial · Interventional
Dietary Intervention in Follicular Lymphoma
Dietary Intervention in Stage III/IV Follicular Lymphoma. Impact on Markers of Cell Proliferation, Apoptosis, Host Immune Cell Infiltrate and Oxidative Stress.
NCT00455416CI-TRIAL-00001470KLYMFunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A dietary intervention study in patients with Follicular Lymphoma (FL) Stage III/IV to assess the ability of several dietary factors to induce apoptosis, inhibit cell proliferation and modulate tumor cell infiltrate in vivo.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Garlic extract (Allicin) | Drug | — | UNRESOLVED |
| Grape juice (resveratrol, quercetin) | Drug | — | UNRESOLVED |
| Green Tea (Epigallocathechin gallate) | Drug | — | UNRESOLVED |
| Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid)) | Drug | — | UNRESOLVED |
| Pomegranate juice (ellagic acid) | Drug | — | UNRESOLVED |
| Selenium (L-Selenomethionine), | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Apoptosis an proliferation rate in tumor cells,
- timeFrame
- At the end of intervention (week 16)
Secondary outcomes (1)
- measure
- Levels of: proinflammatory cytokines,tumor immune cell infiltrate
- timeFrame
- Week 16
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or more. * Permanent address in Norway, located in health region south or east. People living outside these areas in other health regions in Norway may be able to participate but after individual evaluation. * Histologically verified follicular lymphoma grade I or II without clinical signs of transformation to aggressive lymphoma. * Stage III/IV. * Previously untreated or at least 1 year since rituximab treatment or 6 months since cytotoxic chemotherapy. * Not scheduled for disease specific treatment for the next 3 months. * At least one pathological superficial lymph node available for ultrasound guided biopsy. * Cytologically and/or immunocytologically compatible with follicular lymphoma. * Women with childbearing potential, only with use of safe contraceptives Exclusion Criteria: * Gross abnormalities in blood samples. (Hematologic values Hgb\< 10, leukocytes\< 2,5, trombocytes \<100, liver enzymes (ALAT,ASAT,GT,ALP) \> 2,5 x upper normal values,bilirubin \>35 creatinine \>130) * Other serious medical illness (unstable cardiovascular disease, unstable pulmonary disease, uncontrolled diabetes, autoimmunity, chronic infection or other active cancer). * Use of NSAID, ASA the last two weeks prior to enrollment. * Use of systemic corticosteroids the last two months prior to enrollment. * Regular use of anticoagulants as LMW Heparin or warfarin. * Use of carbamazepin, nifedipin and other drugs metabolized with CYP 3A4 where interaction might cause hazardous side effects which cannot be controlled with serum measurements or organ function monitoring. * Inclusion in another clinical trial which involves medication or nutritional supplements. * Use of complementary medicine/alternative medicine which includes high dose\* vitamins or antioxidants/nutritional supplements 2 weeks prior to sampling procedures . * Regularly use of omega 3 fatty acids more than 1g / day * History of serious or unstable medical or psychiatric disorder. * History of heavy alcohol consumption \> 3 units / day. * Pregnancy * Individuals judged by the clinical investigator to be unable to follow instructions and procedures of the study. (\*high dose is defined as vitamins or antioxidant supplements exceeding what is present in regular multi-vitamin supplements covering regular RDAs)
References
Publications (0)
Data not yet available
No reference posted for this study.