Dietary Intervention in Follicular Lymphoma (KLYMF)
Primary Purpose
Follicular Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid))
Selenium (L-Selenomethionine),
Garlic extract (Allicin)
Pomegranate juice (ellagic acid)
Grape juice (resveratrol, quercetin)
Green Tea (Epigallocathechin gallate)
Sponsored by
About this trial
This is an interventional treatment trial for Follicular Lymphoma focused on measuring Low grade lymphoma, Diet, Antioxidants, Non Hodgkin Lymphoma - Follicular Lymphoma grade 1&2 stage III/IV
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)
Sites / Locations
- RRHF RIkshospitalet Radiumhospitalet HFRecruiting
Outcomes
Primary Outcome Measures
Apoptosis an proliferation rate in tumor cells,
Secondary Outcome Measures
Levels of: proinflammatory cytokines,tumor immune cell infiltrate
Full Information
NCT ID
NCT00455416
First Posted
April 2, 2007
Last Updated
May 20, 2008
Sponsor
Oslo University Hospital
Collaborators
University of Oslo
1. Study Identification
Unique Protocol Identification Number
NCT00455416
Brief Title
Dietary Intervention in Follicular Lymphoma
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
Keywords
Low grade lymphoma, Diet, Antioxidants, Non Hodgkin Lymphoma - Follicular Lymphoma grade 1&2 stage III/IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid))
Other Intervention Name(s)
Nycoplus omega-3 1000mg
Intervention Description
1000mgx5 daily
Intervention Type
Drug
Intervention Name(s)
Selenium (L-Selenomethionine),
Other Intervention Name(s)
Solaray selenium 100mcg
Intervention Description
100mcgx2 daily
Intervention Type
Drug
Intervention Name(s)
Garlic extract (Allicin)
Other Intervention Name(s)
Circuline
Intervention Description
6 garlic pearls daily
Intervention Type
Drug
Intervention Name(s)
Pomegranate juice (ellagic acid)
Other Intervention Name(s)
Produced by:Tine Meierier.
Intervention Description
Pomegranate juice 100%, 660ml /495 ml every second day.
Intervention Type
Drug
Intervention Name(s)
Grape juice (resveratrol, quercetin)
Other Intervention Name(s)
Produced by Tine Meierier
Intervention Description
Merlot grape juice 100%, 660ml /495 ml every second day
Intervention Type
Drug
Intervention Name(s)
Green Tea (Epigallocathechin gallate)
Other Intervention Name(s)
Green tea - twinings java green tea
Intervention Description
Green Tea. 2 cups daily
Primary Outcome Measure Information:
Title
Apoptosis an proliferation rate in tumor cells,
Time Frame
At the end of intervention (week 16)
Secondary Outcome Measure Information:
Title
Levels of: proinflammatory cytokines,tumor immune cell infiltrate
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kjell Magne Russnes, MD
Phone
+4722934000
Email
k.m.russnes@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Harald Jr. Holte, MD, PhD
Phone
+4722934000
Email
harald.holte@radiumhospitalet.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald Jr. Holte, MD, PhD
Organizational Affiliation
RRHF Rikshospitalet Radiumhospitalet HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
RRHF RIkshospitalet Radiumhospitalet HF
City
Montebello
State/Province
Oslo
ZIP/Postal Code
0310
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kjell Magne Russnes, MD
Phone
+4722934000
Email
k.m.russnes@medisin.uio.no
First Name & Middle Initial & Last Name & Degree
Harald JR Holte, MD, PhD
Phone
+4722934000
Email
harald.holte@radiumhospitalet.no
First Name & Middle Initial & Last Name & Degree
Harald Jr Holte, Md, PhD
First Name & Middle Initial & Last Name & Degree
Kjell Magne Russnes, MD
12. IPD Sharing Statement
Learn more about this trial
Dietary Intervention in Follicular Lymphoma
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