NCT00455416: KLYMF

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

Status unknown Phase 2 Last updated 20 May 2008

What this trial tests

Phase 2 trial testing Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid)) in Follicular Lymphoma in 45 participants. Status unknown.

Timeline

1 April 2007

Primary endpoint
1 April 2009

1 December 2009

Quick facts

Lead sponsor	Oslo University Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	1 April 2007
Primary completion	1 April 2009
Estimated completion	1 December 2009
Sites	1 location across Norway

Drugs / interventions tested

• Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid)) — full drug profile →
• Selenium (L-Selenomethionine), — full drug profile →
• Garlic extract (Allicin) — full drug profile →
• Pomegranate juice (ellagic acid) — full drug profile →
• Grape juice (resveratrol, quercetin) — full drug profile →
• Green Tea (Epigallocathechin gallate)

Conditions studied

• Follicular Lymphoma — all drugs for Follicular Lymphoma →

Sponsor

Oslo University Hospital

Who can join

18 and older, any sex, with Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Apoptosis an proliferation rate in tumor cells,
  Time frame: At the end of intervention (week 16)

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting oxidative stress in disease: promise and limitations of antioxidant therapy.
   Forman HJ, Zhang H. · · 2021 · cited 1789× · PMID 34194012 · DOI 10.1038/s41573-021-00233-1
2. Perspectives for cancer prevention with natural compounds.
   Amin AR, Kucuk O, Khuri FR, Shin DM. · · 2009 · cited 330× · PMID 19414669 · DOI 10.1200/jco.2008.20.6235
3. Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
   Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
4. Multi-targeted therapy of cancer by omega-3 fatty acids.
   Berquin IM, Edwards IJ, Chen YQ. · · 2008 · cited 240× · PMID 18479809 · DOI 10.1016/j.canlet.2008.03.044
5. Resveratrol and cancer: Challenges for clinical translation.
   Singh CK, Ndiaye MA, Ahmad N. · · 2015 · cited 176× · PMID 25446990 · DOI 10.1016/j.bbadis.2014.11.004
6. Unraveling the Anticancer Effect of Curcumin and Resveratrol.
   Pavan AR, Silva GD, Jornada DH, Chiba DE, et al · · 2016 · cited 73× · PMID 27834913 · DOI 10.3390/nu8110628
7. Plant-Derived Natural Products in Cancer Research: Extraction, Mechanism of Action, and Drug Formulation.
   Talib WH, Alsalahat I, Daoud S, Abutayeh RF, et al · · 2020 · cited 65× · PMID 33202681 · DOI 10.3390/molecules25225319
8. Resveratrol as a Tumor-Suppressive Nutraceutical Modulating Tumor Microenvironment and Malignant Behaviors of Cancer.
   Han Y, Jo H, Cho JH, Dhanasekaran DN, et al · · 2019 · cited 65× · PMID 30791624 · DOI 10.3390/ijms20040925