AzTrials
AzTrials

Follicular LymphomaPhase 2KLYMFNCT00455416

Dietary Intervention in Follicular Lymphoma

A Phase 2 study testing Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid)), Selenium (L-Selenomethionine), and Garlic extract (Allicin) in people with Follicular Lymphoma, run by Oslo University Hospital at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid)), Selenium (L-Selenomethionine), and Garlic extract (Allicin)
How many people
45 participants
Where
1 siteNorway
Study dates
Apr 2007to Dec 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Kjell Magne Russnes, MD contact

+4722934000

k.m.russnes@medisin.uio.no

Harald Jr. Holte, MD, PhD contact

+4722934000

harald.holte@radiumhospitalet.no

Norway1 site, 1 recruiting

  • RRHF RIkshospitalet Radiumhospitalet HF

    Montebello, Oslo, 0310

    Kjell Magne Russnes, MD, +4722934000, k.m.russnes@medisin.uio.no

    Harald JR Holte, MD, PhD, +4722934000, harald.holte@radiumhospitalet.no

    Recruiting

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
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)
Keywords
Low grade lymphoma, Diet, Antioxidants, Non Hodgkin Lymphoma - Follicular Lymphoma grade 1&2 stage III/IV
Medical subject headings
Lymphoma, Follicular, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid))Drug

    Also called Nycoplus omega-3 1000mg

    1000mgx5 daily

  • Selenium (L-Selenomethionine),Drug

    Also called Solaray selenium 100mcg

    100mcgx2 daily

  • Garlic extract (Allicin)Drug

    Also called Circuline

    6 garlic pearls daily

  • Pomegranate juice (ellagic acid)Drug

    Also called Produced by:Tine Meierier.

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

  • Grape juice (resveratrol, quercetin)Drug

    Also called Produced by Tine Meierier

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

  • Green Tea (Epigallocathechin gallate)Drug

    Also called Green tea - twinings java green tea

    Green Tea. 2 cups daily

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Apoptosis an proliferation rate in tumor cells,

    Measured: At the end of intervention (week 16)

Secondary outcomes (1)

  1. Levels of: proinflammatory cytokines,tumor immune cell infiltrate

    Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionApr 2009 (estimated)
  4. Study completionDec 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00455416
Sponsor's protocol ID
Dietary intervention FL
Acronym
KLYMF
Status last verified
Apr 2007
First submitted
2 Apr 2007
Last updated
21 May 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid)), Selenium (L-Selenomethionine), and Garlic extract (Allicin) in people with Follicular Lymphoma, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kjell Magne Russnes, MD (+4722934000, k.m.russnes@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apoptosis an proliferation rate in tumor cells, (time frame: At the end of intervention (week 16)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00455416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in