Dietary Intervention in Follicular Lymphoma

Follicular Lymphoma Clinical Trial

— KLYMF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00455416
• Other study ID #: Dietary intervention FL
• Status: Recruiting
• Phase: Phase 2
• First received: April 2, 2007
• Last updated: May 20, 2008
• Start date: April 2007
• Est. completion date: December 2009

Study information

• Verified date: April 2007
• Source: Oslo University Hospital
• Contact: Kjell Magne Russnes, MD
• Phone: +4722934000
• Email: k.m.russnes[@]medisin.uio.no
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid))
1000mgx5 daily
• Selenium (L-Selenomethionine),
100mcgx2 daily
• Garlic extract (Allicin)
6 garlic pearls daily
• Pomegranate juice (ellagic acid)
Pomegranate juice 100%, 660ml /495 ml every second day.
• Grape juice (resveratrol, quercetin)
Merlot grape juice 100%, 660ml /495 ml every second day
• Green Tea (Epigallocathechin gallate)
Green Tea. 2 cups daily

Locations

Country	Name	City	State
Norway	RRHF RIkshospitalet Radiumhospitalet HF	Montebello	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apoptosis an proliferation rate in tumor cells,		At the end of intervention (week 16)	No
Secondary	Levels of: proinflammatory cytokines,tumor immune cell infiltrate		Week 16	No