Dietary Intervention in Follicular Lymphoma

Original Study ID : Dietary intervention FL

NCT ID : NCT00455416

Brief Title : 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.

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.

Source : Rikshospitalet HF

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.

Overall Status : Recruiting

Start Date : April 2007

End Date : December 2009

Completion Date : December 2009

Official Title : Phase 2

Phase : Interventional

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

Enrollment : 45

Verification Date : April 2007

First Received Date : April 2, 2007

Trial 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)

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : RRHF RIkshospitalet Radiumhospitalet HF

Status : Recruiting

City : Montebello

State : Oslo

Zip Code : 0310

Country : Norway

OutComes

Primary OutComes

Measure : Apoptosis an proliferation rate in tumor cells,

Time Frame : At the end of intervention (week 16)

Safety issue : No

Secondary OutComes

Measure : Levels of: proinflammatory cytokines,tumor immune cell infiltrate

Time Frame : Week 16

Safety issue : No

Interventions

Type : Drug

Name : Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid))

Description : 1000mgx5 daily

Type : Drug

Name : Selenium (L-Selenomethionine),

Description : 100mcgx2 daily

Type : Drug

Name : Garlic extract (Allicin)

Description : 6 garlic pearls daily

Type : Drug

Name : Pomegranate juice (ellagic acid)

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

Type : Drug

Name : Grape juice (resveratrol, quercetin)

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

Type : Drug

Name : Green Tea (Epigallocathechin gallate)

Description : Green Tea. 2 cups daily

Clinical Trial Name - Dietary Intervention in Follicular Lymphoma