Clinical trial NCT00455416: Dietary Intervention in Follicular Lymphoma
Official title: Dietary Intervention in Stage III/IV Follicular Lymphoma. Impact on Markers of Cell Proliferation, Apoptosis, Host Immune Cell Infiltrate and Oxidative Stress.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Follicular Lymphoma
Keywords: Low grade lymphoma
Diet
Antioxidants
Non Hodgkin Lymphoma - Follicular Lymphoma grade 1&2 stage III/IV
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2007-04-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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)

Primary outcomes:
measure: Apoptosis an proliferation rate in tumor cells,
timeFrame: At the end of intervention (week 16)
Secondary outcomes:
measure: Levels of: proinflammatory cytokines,tumor immune cell infiltrate
timeFrame: Week 16
Other outcomes:
Locations:
city: Montebello
country: Norway
facility: RRHF RIkshospitalet Radiumhospitalet HF
state: Oslo
Study officials:
affiliation: RRHF Rikshospitalet Radiumhospitalet HF
name: Harald Jr. Holte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: