KLYMF: Dietary Intervention in Follicular Lymphoma

Sponsor

Oslo University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00455416

Collaborator

University of Oslo (Other)

Enrollment

Location

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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.

Study Start Date :

Apr 1, 2007

Anticipated Primary Completion Date :

Apr 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Outcome Measures

Primary Outcome Measures

Apoptosis an proliferation rate in tumor cells, [At the end of intervention (week 16)]

Secondary Outcome Measures

Levels of: proinflammatory cytokines,tumor immune cell infiltrate [Week 16]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.