Dietary Intervention in Follicular Lymphoma - Full Text View

Sponsors and Collaborators:	Rikshospitalet HF University of Oslo
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00455416

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Diets Lymphoma

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid Quercetin Ellagic acid Resveratrol Allicin Selenomethionine Selenium Allium sativum extract

U.S. FDA Resources

Further study details as provided by Rikshospitalet HF:

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:

1000mgx5 daily

100mcgx2 daily

6 garlic pearls daily

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

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

Green Tea. 2 cups daily

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, Oslo
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

Rikshospitalet HF

University of Oslo

Investigators

Principal Investigator:

Harald Jr. Holte, MD, PhD

RRHF Rikshospitalet Radiumhospitalet HF

More Information

No publications provided

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

Keywords provided by Rikshospitalet HF:

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

Study placed in the following topic categories:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Antioxidants
Allicin
Lymphoma, Follicular
Follicular Lymphoma
Resveratrol
Lymphoma, Small Cleaved-cell, Diffuse
Selenium
Tea
Anti-Inflammatory Agents, Non-Steroidal
Micronutrients
Analgesics
Garlic
Grape

Lymphoma
Immunoproliferative Disorders
Pomegranate
Stress
Trace Elements
Lymphatic Diseases
Analgesics, Non-Narcotic
Omega 3 Fatty Acid
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Antirheumatic Agents
Quercetin
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anticarcinogenic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hematologic Agents
Lymphoma, Follicular
Resveratrol
Selenium
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Micronutrients

Lymphoma
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Growth Substances
Antimutagenic Agents
Trace Elements
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009