Dietary Intervention in Stage III/IV Follicular Lymphoma. Impact on Markers of Cell Proliferation, Apoptosis, Host Immune Cell Infiltrate and Oxidative Stress.
18 Years
N/A
Both
Follicular Lymphoma
Trial Information
Dietary Intervention in Stage III/IV Follicular Lymphoma. Impact on Markers of Cell Proliferation, Apoptosis, Host Immune Cell Infiltrate and Oxidative Stress.
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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Apoptosis an proliferation rate in tumor cells,
Outcome Time Frame:
At the end of intervention (week 16)
Safety Issue:
No
Principal Investigator
Harald Jr. Holte, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
RRHF Rikshospitalet Radiumhospitalet HF
Authority:
Norway: Norwegian Medicines Agency
Study ID:
Dietary intervention FL
NCT ID:
NCT00455416
Start Date:
April 2007
Completion Date:
December 2009
Related Keywords:
- Follicular Lymphoma
- Low grade lymphoma
- Diet
- Antioxidants
- Non Hodgkin Lymphoma - Follicular Lymphoma grade 1&2 stage III/IV
- Lymphoma
- Lymphoma, Follicular
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