Table I.
Intervention trials with omega-3 PUFA for cancer prevention, treatment or patient support.
| Trial no. | Cancer type | Trial type | Title | Outcomes to be measured | Dates/Reference | Phase |
|---|---|---|---|---|---|---|
| NCT00114296 | Breast cancer | Prev. | Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer | Mammographic breast density, atypia in ductal lavage, hormones, lipid peroxidation | 04/05-NS | NS |
| NCT00432913 | Colon cancer | Prev. | Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa | Proliferation and apoptosis in colonic mucosa, measure of tissue EPA, safety and tolerability | 10/06-05/08 | II/III |
| NCT00510692 | Colon cancer | Prev. | Chemoprevention Trial in Familial Adenomatous Polyposis Coli Using EPA | Number/ size of rectal polyps, apoptosis and cell proliferation in the rectal mucosa, EPA and FA uptake, tolerability | 11/06-03/08 | II/III |
| NCT00475722 | Colon cancer | Prev. | Healthy Eating for Colon Cancer Prevention | FA, carotenoids, inflammation mediators | 05/07-10/12 | NS |
| NCT00398333 | Colorectal cancer | Supp. | Study to Assess the Effectiveness of a Omega-3 Enriched Supplement on Chemotherapy Tolerance in Colon Cancer Patients | Tolerance to chemotherapy (QoL), nutritional status | 06/05-NS | IV |
| NCT00488904 | Colorectal cancer | Supp. | Omega-3 Fatty Acids and Postoperative Complications After Colorectal Surgery | Reduction in infectious complications, hospitalization time, mortality | 06/07-01/08 | IV |
| NCT00145015 | Colorectal cancer | Prev. | FishGastro Study: Fish Consumption and Gastro-Intestinal Health | Apoptosis, cell prolif., lymphocyte infiltration, cytokines, prostaglandins, gene expression | 12/04-01/08 | NS |
| NCT00168987 | Colorectal cancer, hepatocellular ca, cholangiocarcinoma | Supp. | Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors | Muscle function, cognitive functions, QoL, tolerance of nutritional supplement, nutritional state | 01/07-06/07 | IV |
| NCT00558155 | Gastric, pancreatic | Supp. | The Impact of Immunostimulating Nutrition on the Outcome of Surgery | Surgical and nonsurgical complications, overall morbidity/mortality, hospital stay | 06/01-12/05 Klek et al, 2005 | IV |
| NCT00559156 | Head and neck | Supp. | Arginine/Omega-3 Fatty Acids/Nucleotides Nutritional Supplement in Treating Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy | Immunomodulatory effect | 06/05-NS | II |
| NCT00333099 | Head and neck, esophageal | Supp. | INEC Study: Immuno-Modulating Enteral Nutrition in Cancer | Anti-inflammation (mucositis),complications, nutritional and immune status, QoL, cost | 05/06-04/09 | IV |
| NCT00533078 | Hematologic malignancies (AML) | Supp. | Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies | Anti-inflammation (colitis) | 11/07-12/08 | II |
| NCT00003077 | Leukemia, Lymphoma, Multiple Myeloma, Plasma Cell Neoplasm | Supp., treat. | Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss | Weight loss prevention, n-3 PUFA maximum tolerated dose, antitumor response | 10/95-NS Burns et al, 2004 | I/II |
| NCT00455416 | Lymphoma | Treat. | Dietary Intervention in Follicular Lymphoma | Tumor cell proliferation, apoptosis, immune cell infiltrate, cytokines | 04/07-12/09 | II |
| NCT00292279 | Multiple cancers | Supp. | The Impact of Fish Oil Emulsion on Clinical Outcome of Post-Operative Cancer Patients | Infection, inflammation, hosp. days, cost | 06/02-03/06 | III |
| NCT00031707 | Multiple cancers (excl. brain, breast, prostate, ovarian, endometrial) | Supp. | Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite | Weight, appetite, nausea, vomiting, QoL, toxicity, overall survival, IL-6 | 03/00-NS Jatoi et al, 2004 | III |
| NCT00094562 | Multiple cancers and other diseases associated with cachexia | Supp. | A Fish Oil Supplement Maintain Body Weight Patients With Disease-Related Weight Loss | Body weight, lean body mass, QoL, anti-inflammatory, anticatabolic, anti-oxidant and anabolic actions | 06/04-09/06 | II |
| NCT00253643 | Prostate cancer | Prev. | Fish Oil in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia or Who Are at for Developing Prostate Cancer | Proliferation, lipid metabolism: FASN, SREBP, apoptosis, bone loss | 07/05-NS | NS |
| NCT00049309 | Prostate cancer | Prev. | Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer | Proliferation, apoptosis, PSA and other biomarkers | 01/03-05/06 | II |
| NCT00402285 | Prostate cancer | Treat. | Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer | Gene expression pattern, correlation with diet, lack of progression | 04/03-NS | NS |
| NCT00458549 | Prostate cancer | Treat. | Polyunsaturated Fatty Acids in Treating Patients With Prostate Cancer Undergoing Prostate Biopsy and/or Surgery | eIF2α phosphorylation, relapse-free survival | 07/06-NS | NS |
| NCT00433797 | Prostate cancer | Treat. | Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients | PSA, biomarkers of inflammation, antioxidant, oxidative stress, oxidative damage | 03/07-03/09 | I/II |
Prev.: prevention, Supp.: support, Treat.: treatment, NS: not specified, QoL: quality of life.