Dietary Intervention in Follicular Lymphoma

NCT00455416 | Unknown Phase 2

• 1 other identifier: Dietary intervention FL
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Follicular Lymphoma

Keywords

Low grade lymphoma; Diet; Antioxidants; Non Hodgkin Lymphoma - Follicular Lymphoma grade 1&2 stage III/IV

Outcome Measures

Primary Outcomes (1)

• Apoptosis an proliferation rate in tumor cells,

  At the end of intervention (week 16)

Secondary Outcomes (1)

• Levels of: proinflammatory cytokines,tumor immune cell infiltrate

  Week 16

Interventions

Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid)) DRUG

1000mgx5 daily

Also known as: Nycoplus omega-3 1000mg

Selenium (L-Selenomethionine), DRUG

100mcgx2 daily

Also known as: Solaray selenium 100mcg

Garlic extract (Allicin) DRUG

6 garlic pearls daily

Also known as: Circuline

Pomegranate juice (ellagic acid) DRUG

Pomegranate juice 100%, 660ml /495 ml every second day.

Also known as: Produced by:Tine Meierier.

Grape juice (resveratrol, quercetin) DRUG

Merlot grape juice 100%, 660ml /495 ml every second day

Also known as: Produced by Tine Meierier

Green Tea (Epigallocathechin gallate) DRUG

Green Tea. 2 cups daily

Also known as: Green tea - twinings java green tea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

RRHF RIkshospitalet Radiumhospitalet HF

Montebello, Oslo County, 0310, Norway

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, Non-Hodgkin

Interventions

Fatty Acids, Omega-3; Eicosapentaenoic Acid; Docosahexaenoic Acids; Selenium; allicin; Ellagic Acid; Resveratrol; Quercetin; Tea

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Eicosanoids; Chalcogens; Elements; Inorganic Chemicals; Minerals; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Flavonols; Flavonoids; Chromones; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Harald Jr. Holte, MD, PhD

  RRHF Rikshospitalet Radiumhospitalet HF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kjell Magne Russnes, MD

CONTACT

+4722934000; k.m.russnes@medisin.uio.no

Harald Jr. Holte, MD, PhD

CONTACT

+4722934000; harald.holte@radiumhospitalet.no

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2007
• First Posted: April 3, 2007
• Study Start: April 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 21, 2008

Record last verified: 2007-04

Locations

NO (1)