Dietary Intervention in Follicular Lymphoma (KLYMF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00455416
First received: April 2, 2007
Last updated: May 20, 2008
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Follicular Lymphoma
Drug: Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid))
Drug: Selenium (L-Selenomethionine),
Drug: Garlic extract (Allicin)
Drug: Pomegranate juice (ellagic acid)
Drug: Grape juice (resveratrol, quercetin)
Drug: Green Tea (Epigallocathechin gallate)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dietary Intervention in Stage III/IV Follicular Lymphoma. Impact on Markers of Cell Proliferation, Apoptosis, Host Immune Cell Infiltrate and Oxidative Stress.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Apoptosis an proliferation rate in tumor cells, [ Time Frame: At the end of intervention (week 16) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Levels of: proinflammatory cytokines,tumor immune cell infiltrate [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: April 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid))
    1000mgx5 daily
    Other Name: Nycoplus omega-3 1000mg
    Drug: Selenium (L-Selenomethionine),
    100mcgx2 daily
    Other Name: Solaray selenium 100mcg
    Drug: Garlic extract (Allicin)
    6 garlic pearls daily
    Other Name: Circuline
    Drug: Pomegranate juice (ellagic acid)
    Pomegranate juice 100%, 660ml /495 ml every second day.
    Other Name: Produced by:Tine Meierier.
    Drug: Grape juice (resveratrol, quercetin)
    Merlot grape juice 100%, 660ml /495 ml every second day
    Other Name: Produced by Tine Meierier
    Drug: Green Tea (Epigallocathechin gallate)
    Green Tea. 2 cups daily
    Other Name: Green tea - twinings java green tea
Detailed Description:

Dietary factors plays an important role in the prevention of several diseases. The cardiovascular disease mortality have dropped dramatically the last 20 years, but the relative death rates from cancer remains fairly stable. There is reason to believe that factors in the tumors microenvironment is of great importance for the outcome of many malignant diseases, including FL. Factors predicting a poor outcome are associated with inflammation, oxidative stress which both impair the hosts immune response and produces growth stimulatory signals. In this open study with 45 patients to be included we seek to perform a dietary intervention with comparison of apoptosis rate, proliferation rate and immune cell infiltrate before and after the intervention period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455416

Contacts
Contact: Kjell Magne Russnes, MD +4722934000 k.m.russnes@medisin.uio.no
Contact: Harald Jr. Holte, MD, PhD +4722934000 harald.holte@radiumhospitalet.no

Locations
Norway
RRHF RIkshospitalet Radiumhospitalet HF Recruiting
Montebello, Oslo, Norway, 0310
Contact: Kjell Magne Russnes, MD    +4722934000    k.m.russnes@medisin.uio.no   
Contact: Harald JR Holte, MD, PhD    +4722934000    harald.holte@radiumhospitalet.no   
Principal Investigator: Harald Jr Holte, Md, PhD         
Sub-Investigator: Kjell Magne Russnes, MD         
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
Principal Investigator: Harald Jr. Holte, MD, PhD RRHF Rikshospitalet Radiumhospitalet HF
  More Information

No publications provided

Responsible Party: Harald Holte MD, PhD, Rikshospitalet-Radiumhospitalet HF
ClinicalTrials.gov Identifier: NCT00455416     History of Changes
Other Study ID Numbers: Dietary intervention FL
Study First Received: April 2, 2007
Last Updated: May 20, 2008
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Low grade lymphoma
Diet
Antioxidants
Non Hodgkin Lymphoma - Follicular Lymphoma grade 1&2 stage III/IV

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Quercetin
Selenium
Allicin
Resveratrol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances
Anti-Infective Agents
Therapeutic Uses
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hypoglycemic Agents
Free Radical Scavengers
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on April 14, 2014