Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
45 participants
INTERVENTIONAL
2007-04-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid))
1000mgx5 daily
Selenium (L-Selenomethionine),
100mcgx2 daily
Garlic extract (Allicin)
6 garlic pearls daily
Pomegranate juice (ellagic acid)
Pomegranate juice 100%, 660ml /495 ml every second day.
Grape juice (resveratrol, quercetin)
Merlot grape juice 100%, 660ml /495 ml every second day
Green Tea (Epigallocathechin gallate)
Green Tea. 2 cups daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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University of Oslo
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Rikshospitalet-Radiumhospitalet HF
Principal Investigators
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Harald Jr. Holte, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
RRHF Rikshospitalet Radiumhospitalet HF
Locations
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RRHF RIkshospitalet Radiumhospitalet HF
Montebello, Oslo County, Norway
Countries
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Central Contacts
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Facility Contacts
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Kjell Magne Russnes, MD
Role: primary
Harald JR Holte, MD, PhD
Role: backup
Other Identifiers
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Dietary intervention FL
Identifier Type: -
Identifier Source: org_study_id