Neoplasms

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Adenomatous Polyposis Coli

Polyps

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Adenomatous Polyps

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

Other Dietary Supplements

All Drugs and Chemicals

Herbal and Botanical

Omega 3 Fatty Acid

Cola

Eicosapentanenoic Acid (EPA) as the free fatty acid 2 capsules twice daily for 6 months.

Endoscopy and biopsies taken as described under intervention.

Medium chain triglycerides 2 capsules twice daily for six months. Endoscopy and biopsies taken as described under intervention.

2 x 500mg EPA capsules twice daily for 6 months

Eicosapentanoic Acid (EPA)

Endoscopy with video and photographs at baseline and month 6.

Endoscopy

9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).

Biopsies taken

2 x 500mg placebo capsules twice daily for 6 months

Placebo

Nicholas J West, MB BS FRCS

This purpose of this study is to investigate whether the number and size of rectal polyps can be reduced in patients with Familial Adenomatous Polyposis (FAP) by using a highly-purified form of a naturally occurring substance, the omega-3 fatty acid, eicosapentaenoic acid (EPA).

It has been found that people who consume a large amount of oily fish tend to have a lower risk of developing colon cancer. This is thought to be due to the omega-3 fatty acids present in oily fish, one of which is EPA. The effect of taking a 99% pure form of EPA (2g per day) compared with placebo capsules on the number and size of polyps in the rectum over a six month period will be investigated.

FAP is an inherited susceptibility to diffuse colorectal adenomas and colorectal carcinoma, occurring in close to 100% of unresected colons. It is caused by a germline mutation in the Adenomatous Polyposis Coli (APC) gene located in the long arm of chromosome 5. To prevent cancer development it is recommended that patients with FAP undergo colectomy with ileo-anal or ileo-rectal anastomosis (or colectomy and end-ileostomy) at a socially convenient time before polyp progression to malignancy and before the age of 25. Patients with the attenuated FAP phenotype, often associated with mutations at the 5' terminus (exon 4 and proximally), have fewer polyps and may often delay colectomy. Patients with an ileo-rectal anastomosis are still susceptible to polyp formation in the remaining rectal stump and require 6 monthly check-ups with a flexible sigmoidoscope with removal of any polyps that develop. Therefore, an effective chemopreventative agent with a favourable side-effect profile would be of benefit to FAP patients with ileo-rectal anastomosis (IRA) and recurrent rectal polyps in addition to young adults who prefer to delay colectomy. If such an agent were to be effective in FAP patients in the prevention of colonic polyps, it may also be of benefit to the larger population of patients with sporadic colorectal adenomatous polyps who are also at risk of colorectal cancer.

Colorectal polyps are thought, at least in part, to arise from an imbalance in the levels of cell proliferation and apoptosis (natural cell death) in the colonic mucosa. It has been suggested that omega-3 polyunsaturated fatty acids (PUFAs) in fish oil can manipulate the high levels of colonic-mucosal cell proliferation rates associated with colonic adenomas.

The rationale for this trial is based on the increasing evidence linking inflammatory processes and the development of a number of cancers, including bowel cancer. This has focused attention on the role of inflammatory mediators in the development of cancer. In particular, the family of eicosanoids (including 2-series prostaglandins, 4-series leukotrienes and thromboxanes) produced through conversion of the omega-6 PUFA, arachidonic acid, via cyclo-oxygenase-2 (COX-2) is believed to contribute to the physiological processes of inflammation and the development of tumours. Prostaglandin E2, a product of the conversion of arachidonic acid via the COX-2 pathway, has been implicated in tumourigenesis through:

1. promotion of angiogenesis
2. anti-apoptotic properties
3. increasing expression of matrix metalloproteinases and hence the ability of a tumour cell to undergo metastasis
4. altering the cytokine expression profile of cells.

The class of eicosanoid synthesised will depend on the PUFA substrate. Whilst arachidonic acid is converted to 2-series prostaglandins and 4-series leukotrienes, EPA is converted to 3-series prostaglandins and 5-series leukotrienes. Overall, the latter eicosanoids are less potent as inflammatory mediators than those derived from arachidonic acid.

Increasing daily intake of EPA, the omega-3 PUFA analogue of arachidonic acid, alters the balance between the cell content of these fatty acids. This results in reduced production of the more active inflammatory/tumourigenic products of arachidonic acid metabolism. This is supported by the results of recent work at St George's Hospital Medical School, London. In patients with a history of colonic adenomas, daily dosing with a highly purified, free-fatty acid form of the EPA produced a significant reduction in cell proliferation and increase in apoptosis in the colonic mucosa. This preparation of EPA has the proprietary name "Alfa" and is referred to here as EPA.

This proposed study will be based upon the randomised, placebo-controlled National Cancer Institute sponsored study in which three groups of FAP patients were assigned to one of two doses of celecoxib (a COX-2 inhibitor) or placebo. The results showed a reduction in the polyp burden of the group taking the higher (400mg twice daily (bd)) dose. However, there is evidence to suggest that COX-2 inhibitors carry significant potential for side-effects. Adopting a similar design, EPA will be substituted for celecoxib in this randomised, placebo-controlled trial, comparing 2g EPA to placebo, with reduction in polyp burden as the primary objective.

Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Using EPA

A Two-Arm Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Patients Using the Purified Free Fatty Acid, Eicosapentaenoic Acid

Absolute change in the number of polyps measured in a defined focal area of the rectum.

Percentage change in the number of polyps measured in the defined focal area of the rectum in subjects treated with EPA compared to subjects receiving placebo.

Change in global rectal polyp burden in subjects treated with Eicosapentanoic Acid (EPA) compared to subjects receiving placebo. Each reviewer in the Polyp Video Scoring Committee assessed global colorectal polyp burden change as "better", "same as" or "worse". The qualitative assessment was assigned a score of +1 for "better", 0 for "same as" and -1 for "worse". Thereafter a mean overall reviewers score was calculated.

Relative EPA concentration of total free fatty acids in the rectal mucosa of subjects with FAP.

Incidence of adverse events in each treatment group.

S.L.A. Pharma AG

Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months

Endoscopy: With video and photographs at baseline and month 6.

Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).

2g/Day Eicosapentanoic Acid (EPA)

Medium chain triglycerides 2 capsules twice daily for six months.

Endoscopy: With video and photographs at baseline and month 6.

Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).

2g/Day EPA

Total

Age, Continuous

Age, Categorical

Sex: Female, Male

United Kingdom

Region of Enrollment

The baseline characteristics are presented for the full analysis set which constitutes 55 of the 58 randomised subjects. The full analysis set includes all subjects who were randomised into the study, took at least one dose of study medication provided both at baseline and at least one treatment measurement for efficacy.

Dr Chris Jordan

Eicosapentaenoic Acid (EPA) 2g per day for six months

2g/Day Eicosapentaenoic Acid (EPA)

Medium chain triglycerides 2g per day for six months

13 subjects lacked the photographs required for counting the measurements of polyps. Reasons for lack of photographs varied including failure of video equipment, inability to identify identical views of the focal area and no forceps visible for calibration.

Absolute Change in the Number of Polyps Measured in a Focal Area of the Rectum.

Percentage Change in the Number of Polyps Measured in the Defined Focal Area of the Rectum.

5 subjects in the full analysis set lacked the video required for determining global rectal polyp burden due to failure of equipment.

Change in Global Rectal Polyp Burden.

3 subjects in the full analysis set had no samples for analysis.

Relative EPA Concentration of Total Free Fatty Acids in the Rectal Mucosa.

Number of Subjects With Adverse Events.

Medium chain triglycerides 2 g per day for six months.

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Body Weight

Weight Loss

Breast Diseases

Skin Diseases

Body Weight Changes

Menopause

Participants will be instructed to follow a diet that is reduced by 500-700 kcal/day below maintenance requirements for 24 weeks or until the individual has reached a BMI of 25kg/m2 (generally 1000-2000 calories/day). Participants will be given one capsule of Omega-3 FA (fatty acids) a day beginning 2 weeks after starting their diet and exercise routine. Omega-3 FA will be increased by 1 capsule/day or every other day until participant is taking 5 capsules per day.Each Amber 4020 Ethyl Ester (EE) 1000 mg omega-3 capsule contains 420 mg of EPA and 210 mg of DHA both as the ethyl esters (380 mg EPA and 190 mg DHA)

Participants will be instructed to exercise and follow a diet that is reduced by 500-700 kcal/day below maintenance requirements for 24 weeks or until the individual has reached a BMI of 25kg/m2 (generally 1000-2000 calories/day). Participants will be given one capsule of placebo a day beginning 2 weeks after starting their diet and exercise routine. Placebo capsule will be increased by 1 capsule/day or every other day until participant is taking 5 capsules per day.

Amber 4020 Ethyl Ester (EE) 1000 mg omega-3 capsule contains 420 mg of EPA and 210 mg of DHA both as the ethyl esters (380 mg EPA and 190 mg DHA)

Omega-3 Fatty Acids

Placebo Capsule

Increasing physical activity required over 6 month period to be tracked by a Fitbit. Diet based on caloric intake and eating approved foods.

Diet and Exercise

Carol J. Fabian, M.D.

The purpose of this study is to determine if high dose supplementation with the omega-3 fatty acids EPA and DHA, when added to a weight loss program, is well tolerated in the study population and if there is an increase in the favorable change in blood and tissue breast cancer risk factors when compared to weight loss alone.

Subjects will all participate in a 6-month weight loss intervention. Subjects will be randomized to receive either blinded placebo or omega-3 fatty acids for 6 months.

Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women

Randomized Pilot Trial of Omega-3 Fatty Acids or Placebo in Peri- or Post-Menopausal Women at High Risk for Breast Cancer Undergoing a Weight Loss Intervention

Measured as the number of participants that dropout before diet+intervention period is complete

Based on eligibility criteria, study procedures and participation of subjects the study design will be measured to see if it will practically work with a larger study population

Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers

Measure change in fasting and postprandial blood inflammatory, and risk biomarkers

Measure change in weight in participants during the 6-12 month maintenance phase

Change in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA):arachidonic acid (AA) ratio

DSM Nutritional Products, Inc.

Carol Fabian, MD

Professor, Director Breast Cancer Prevention Unit

Colonic Polyps

Pathological Conditions, Anatomical

Hematinics

Anti-Infective Agents

Liver Extracts

Carbamide Peroxide

Either 2 x 500mg EPA capsules in the morning and evening (2g per day EPA) or 1 x 500mg EPA and 1 x placebo in the morning and evening (1g per day EPA)

Eicosapentaenoic Acid (EPA)

9 biopsies taken for measurement of apoptosis (3 biopsies), cell proliferation (3 biopsies) and fatty acid levels (3 biopsies) at baseline, month 3 and month 6.

Full blood count at baseline, month 3 and month 6.

Clinical chemistry

Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.

Haematology

Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.

Physical examination

Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.

Vital signs

For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.

Urine pregnancy test

Subjects are requested to complete when study medication is taken and in any new or unusual symptoms are experienced on a daily basis for 6 months.

Completion of patient diary card

The purpose of this study is to determine the effect of two doses purified EPA (an omega-3 fatty acid), on apoptosis (natural cell death) and cell proliferation (formation of new cells) in the lining of the colon for patients with a history of colonic polyps.

Colorectal cancer is generally accepted to develop from changes within colonic adenomatous polyps. More than 90% of new large bowel cancers arise sporadically. The molecular events leading to the development of colorectal cancer from polyps are characterised by an imbalance in cell proliferation (formation of new cells) and apoptosis (natural cell death) from changes in the genes involved in normal colon cells.

Recent work at St George's Hospital Medical School, London, has shown significant beneficial effects on cell proliferation and apoptosis rates in the lining of the colon in subjects with a history of colonic adenomas using a highly purified, free-fatty acid form of eicosapentaenoic acid (EPA).

Comparator(s): 2g EPA per day for 6 months and 1g EPA per day for 6 months will be compared against placebo for 6 months.

Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa

The Effect of Two Dose Levels of Eicosapentaenoic Acid (EPA) on Apoptosis and Cell Proliferation in the Colonic Mucosa of Patients With a History of Colonic Polyps.

Eicosapentaenoic acid free fatty acid (EPA-FFA) 500mg

500mg capsule, two 500mg capsules to be taken twice daily for 24 months

Eicosapentaenoic acid free fatty acid (EPA-FFA)

Luigi Ricciardiello, MD

2 Year randomised, double-blind, placebo-controlled, parallel group study to determine the safety and efficacy of EPA-FFA gastro resistant capsules in FAP.

The purpose of this Phase III study is to determine whether Eicosapentaenoic acid-free fatty acid is a safe and well tolerated treatment in reducing the number of polypectomies FAP patients with an APC gene mutation have over a 2 year treatment period and to assess the effect that this has on clinical disease progression. Planned Sample Size This study will enrol 204 subjects (102 subjects per treatment group). Primary Objective is to determine the efficacy of EPA-FFA gastro-resistant capsules in patients with FAP in reducing polypectomy.

Secondary objectives is to evaluate the clinical disease progression and the long-term safety and tolerability of EPA-FFA.

Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis

Randomised, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Tolerability of EPA-FFA Gastro-resistant Capsules, in Patients With Familial Adenomatous Polyposis (FAP)

Proctectomy is indicated when polyp burden is frequently high in the remaining rectum, if large highly dysplastic polyps occur, or if frank malignancy develops. Proctocolectomy also significantly reduces the cancer risk with the removal of the colon and rectum.

Subsequent proctectomy is indicated when polyp burden is frequently high in the remaining rectum, if large highly dysplastic polyps occur, or if frank malignancy develops. Proctocolectomy also significantly reduces the cancer risk with the removal of the colon and rectum.

Classified stage on InSiGHT Polyposis Staging System (IPSS). The subjects FAP will be classified in accordance with the IPSS.

The IPSS classification will be verified by the Polyp Video Scoring committee

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Inflammation

Hyperplasia

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Sunflower

3g per day of purified EPA, capsules, to be taken once a day, for 14 months.

3 g per day of high-oleic sunflower oil capsules, to be taken once a day, for 14 months.

3g/day of purified EPA , capsules, taken once daily, for 14 months

3g/day of placebo (high oleic sunflower oil) , capsules, taken once daily, for 14 months

Vincent Fradet, MD, PhD

Prostate cancer, the most frequently diagnosed cancer among occidental men, is associated with a major individual and societal burden. Although still controversial, the literature suggests that a high consumption of omega-3 fatty acids (ω3) has protective effects against prostate cancer. One of the proposed mechanisms of action of ω3 lies in their anti-inflammatory properties. In addition, there are some observational evidences suggesting an association of ω3 intake with a lower rate of depression in cancer patients. However, no clinical study has tested the efficacy of ω3 supplementation on psychological and quality of life outcomes in that population. Several evidences point to a possible involvement of inflammation in psychological issues. Reducing the systemic inflammatory state may have beneficial impact on the quality of life of these patients. Preliminary work from this team of investigators, in a cohort of patients managed with active surveillance for their low-grade prostate cancer, show a strong inverse association between the risk of prostate cancer progression (to high-grade) and the level of prostatic eicosapentanoic acid (EPA- a type of ω3).

HYPOTHESIS: EPA-rich monoglycerides fish oil (MAG-EPA) has global positive effects on prostate cancer cell proliferation, inflammation and on the patient's psychosocial functioning and quality of life.

The investigators propose a double blind, randomized controlled clinical trial. 130 consecutive patients suffering from high-risk prostate cancer who choose to be treated by radical prostatectomy will be eligible to this study. The presence of high-grade cancer will be mandatory.

The intervention, a daily supplementation with 3g supplement of fish oil monoglycerides rich in EPA, vs. placebo capsules containing high oleic sunflower oil, will start six weeks before the prostatectomy and will continue for one year after surgery. The potential confounding variables will be measured before the start of the intervention: age, anthropometric parameters, stage and clinical and pathological tumor grade (Gleason score), pre-operative level of prostate specific antigen and diet.

This project proposes a simple intervention by dietary supplementation that could eventually help to reduce the incidence and/or progression of prostate cancer, and the consequences of its treatment, and thus could contribute to diminish the heavy individual and societal burden of prostate cancer. The clinical data generated by this trial will serve as solid basis for a large-scale phase III clinical trial.

Effects of EPA on Prostate Cancer Cells Proliferation and Quality of Life

Étude randomisée, contrôlée, de Phase II, Effets d'un Supplement d'oméga-3 (EPA) Sur l'Inflammation, la prolifération Cellulaire et la qualité de Vie Chez Des Patients Avec Cancer de la Prostate traités Par Prostatectomie Radicale

The difference of fatty acid levels between both groups, relative to baseline, will be quantified using gas chromatography coupled with mass spectrometry and expressed as relative percentages of total fatty acids.

The difference of fatty acid levels between both groups at prostatectomy will be quantified using gas chromatography coupled with mass spectrometry and expressed as relative percentages of total fatty acids, and in absolute level (mg per gram of tissue).

The difference in perioperative bleeding, laboratory tests (hemoglobin, hematocrit and platelets) and surgical complications between both group will be examined at surgery.

Pathological reclassification of cancer grade (ISUP grading system) and stage between the prostate diagnostic biopsy and the prostatectomy specimen will be compared between both groups.

PSA change relative to baseline will be measured for both groups.

The biochemical recurrence, defined as a PSA level ≥ 0.2 ng/mL after reaching a non-detectable level at three months post-surgery, will be evaluated for both groups.

At 6 weeks post study entry, the prostate of the patient will be removed by prostatectomy. The tissue will be preserved in paraffin blocks. The tumour will be identified and the level of Ki-67 in the tumour will be quantified.

The changes in levels of systemic inflammatory mediators, relative to their baseline levels, at the time of radical prostatectomy and at one year post-radical prostatectomy, will be measured. The levels of mediators will be expressed in pg/mL and quantified using validated techniques.

The differences in the levels of expression of inflammatory mediators between both treatment groups will be measured in the peripheral zone of the prostate before surgical prostate dissection/ischemia. The levels of mediators will be expressed in pg/mL and quantified using validated techniques. Further validation could be performed using immunohistochemistry techniques.

Validated questionnaires will be used to measure the modulation of the treatment on Quality of Life of the patients, which will include questions on mood, anxiety levels, sleep and cognition.

Validated questionnaires will be used to measure the modulation of the treatment on psychosocial functioning of the patients, which will include questions on mood, anxiety levels, sleep and cognition.

The impact of changes in inflammatory mediators levels induced by EPA supplementation on quality of life scores will be measured. To do so, we will use appropriate and powerful statistical tests.

The impact of changes in inflammatory mediators levels induced by EPA supplementation and changes in psychosocial functioning scores will be measured. To do so, we will use appropriate and powerful statistical tests.

CHU de Quebec-Universite Laval

Single arm study: Omega-3 enriched fruit juice in increasing dosage

Different doses of omega-3 will be administered to five different groups:

400, 800, 1200, 2400 and 3000 mg/m2.

Omega-3 enriched fruit juice

Per Kogner, Professor

The purpose of this study is to find an optimal dose of omega-3 that can be given to children who have completed cancer therapy. The future aim is to add omega-3 to conventional cancer treatment modalities and thereby hopefully increase the treatment efficacy, which will have to be addressed in subsequent phase-2 studies.

The rationale for this phase-1 trial is to find an appropriate dose of omega-3 for future phase-2 studies. The investigators aim at defining a dose that can safely be given to children previously treated for cancer, and that does not cause unacceptable side effects. In a longer perspective, randomized control trials are planned where the supplement is given for longer periods of time, and in combination with conventional cancer treatment. In preparation for these trials, this dose finding study was designed that also evaluates compliance. Subsequently the investigators hope that this supplementation can be beneficial for children during both cancer treatment and after remission.

The study population consists of children judged to be in complete clinical remission from cancer. In a phase 1 trial, one usually uses healthy individuals as study subjects, but in pediatric studies this is not allowed. Therefore patients who are in full remission were chosen as study objects, but who still come to the clinic for regular follow-ups. This group of patients is relevant for this study since it represents all ages and base-line diets, all kinds of childhood cancers, and because they have suffered from cancer and in many cases still live with the severe consequences of it.

The study is designed to give five groups of eight individuals each different doses of omega-3 adjusted to body surface area. The first group starts out on a dose of omega-3 fatty acids that is similar to the generally recommended daily intake for adults (200-400 mg). A dose escalation is then done performed group wise. The highest possible dose in this study (2 x 3000mg/day at dose level 3000 mg/m2 to a child at 1.55 m2, 3871 mg/m2) is still lower than what has previously been given as maximum to children in other studies. The investigators will keep escalating the dose level within the study only as long as no unacceptable side effects are reported.

The administration is done orally by drinking 200 mL of omega-3 supplemented fruit juice daily. It has a good fruity taste, low amounts of sugar, and no fish flavour. This should facilitate treatment compliance for the children in particular compared to when omega-3 is given in capsules - the commonest choice in other studies, but less suitable for children. Compliance is important and not further jeopardized by trying to divide the fruit juice in less amounts than the whole package, but the individually prescribed dose as well as the actual amount ingested will be recorded and exact calculations used in the analysis of the study.

All study results are primarily evaluated on an intention-to-treat basis, but will also be calculated as treated per protocol and further calculated on the exact dose consumed over 90 days given the compliance in terms of consumed number of fruit juice packages.

OmegaChild - Omega-3 Supplementation to Children Previously Treated for Cancer

OmegaChild - Omega-3 Supplementation to Children Now in Full Remission From a Previous Cancer; an Early Phase Dose-finding Study.

Compliance is calculated in percentage (%) using the number of fruit juice packages actually consumed (according to patient diary and interview) / number of packages prescribed (one or two daily pending dose level and body surface area).

Omega-3 index is defined as % of DHA + EPA of total fatty acids in erythrocyte membranes.

(DHA: Docosahexaenoic acid. EPA: Eicosapentaenoic acid).

Adverse events will be graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Using EPA	NCT00510692	Familial Adenom... FAP	Eicosapentanoic... Endoscopy Biopsies taken Placebo	18 Years -	S.L.A. Pharma AG
Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women	NCT02101970	Breast Cancer	Omega-3 Fatty A... Placebo Capsule Diet and Exerci...	45 Years - 70 Years	University of Kansas Medical Center
Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Using EPA	NCT00510692	Familial Adenom... FAP	Eicosapentanoic... Endoscopy Biopsies taken Placebo	18 Years -	S.L.A. Pharma AG
Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa	NCT00432913	Adenomatous Pol...	Eicosapentaenoi... Endoscopy Biopsies taken Clinical chemis... Haematology Physical examin... Vital signs Urine pregnancy... Completion of p...	18 Years -	S.L.A. Pharma AG
Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis	NCT03806426	Familial Adenom...	Eicosapentaenoi... Placebo	18 Years - 65 Years	S.L.A. Pharma AG
Effects of EPA on Prostate Cancer Cells Proliferation and Quality of Life	NCT02333435	Prostate Cancer	EPA Placebo	18 Years -	CHU de Quebec-Universite Laval
OmegaChild - Omega-3 Supplementation to Children Previously Treated for Cancer	NCT02134600	Pediatric Cance...	Omega-3 enriche...	2 Years - 18 Years	Karolinska Institutet
Impact of Smoking Information on Concerns About Radon	NCT03499535	Lung Neoplasms Radon Exposure Smoking Intention Risk Reduction ...	Radon & Smoking... Radon Only Radon and Smoki... EPA Idaho	18 Years -	University of Iowa

Spots Global Cancer Trial Database for epa

Every month we try and update this database with for epa cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for epa

Every month we try and update this database with for epa cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for epa cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.