Dietary Intervention in Follicular Lymphoma (KLYMF)

May 20, 2008 updated by: Oslo University Hospital

Dietary Intervention in Stage III/IV Follicular Lymphoma. Impact on Markers of Cell Proliferation, Apoptosis, Host Immune Cell Infiltrate and Oxidative Stress.

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.

Study Overview

Status

Unknown

Conditions

Follicular Lymphoma

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- Oslo
  - Montebello, Oslo, Norway, 0310
    - Recruiting
    - RRHF RIkshospitalet Radiumhospitalet HF
    - Contact:
      
      Kjell Magne Russnes, MD
      
      Phone Number: +4722934000
      
      Email: k.m.russnes@medisin.uio.no
    - Contact:
      
      Harald JR Holte, MD, PhD
      
      Phone Number: +4722934000
      
      Email: harald.holte@radiumhospitalet.no
    - Principal Investigator:
      
      Harald Jr Holte, Md, PhD
    - Sub-Investigator:
      
      Kjell Magne Russnes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Apoptosis an proliferation rate in tumor cells, Time Frame: At the end of intervention (week 16)	At the end of intervention (week 16)

Secondary Outcome Measures

Outcome Measure	Time Frame
Levels of: proinflammatory cytokines,tumor immune cell infiltrate Time Frame: Week 16	Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo

Investigators

Principal Investigator: Harald Jr. Holte, MD, PhD, RRHF RIkshospitalet Radiumhospitalet HF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Anticipated)

April 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

April 2, 2007

First Submitted That Met QC Criteria