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

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Micronutrients

Selenium

Antioxidants

Pomegranate

Tomato

Grape

Soy Bean

Patients with localized prostate cancer are supplemented with either tomato or a multi-diet cinsisting of grape juice, pomegranate juice, tomato, green tea, black tea, soy, selenium and PUFAs for 3 weeks.

Prostate cancer, phytochemical and PUFA

Wolfgang Lilleby, MD

Sigbjørn Smeland, MD, PhD.

We will study the effect of dietary intervention in patients with prostate cancer. Outcomes include serum PSA kinetics, as well as biomarkers of inflammation, antioxidant status, oxidative stress and oxidative damage in blood cells, plasma, urine and prostate tissues

A total of 102 patients with localized prostate cancer will be included in the study. A the time of inclusion, the participants will be randomized to three groups.

The intervention groups includes; control group, tomato group and multi-diet group. The intervention period is three week and will be completed before prostatectomy or radiation therapy.

Biomarkers og inflammation includes: acute phase proteins, cytokines, chemokines and other inflammatory mediators. Biomarker of antioxidant status includes vitamin C, vitamin E, glutathione, carotenoids, total antioxidant capacity and total phenolics. Oxidative stress markers includes; malondialdehyde, isoprostanes, 8-hydroxy-deoxyguanosine, oxidized vitamin C, total lipidperoxides (d-ROM) and protein carbonyls.

Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients

Prostate Phytochemical & PUFA Intervention - a Phase I/II Study

Oslo University Hospital

Norwegian Cancer Society

The Research Council of Norway

University of Oslo

Professor

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.

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Polycystic Ovary Syndrome

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

Insulin

Insulin, Globin Zinc

English Walnut

Patients will be randomized to receive walnuts

Patients will be randomized to receive almonds

Subjects will follow their usual diet for 4 weeks; after that they will be randomized to walnuts. They will eat walnuts once daily for six weeks.

walnuts

Subjects will follow their usual diet for 4 weeks; after that they will be randomized to almonds. They will eat almonds once daily for six weeks.

almonds

Sidika E Kasim-Karakas, MD

The purpose of this study is to learn more about the effects of walnuts, walnut-oil, almonds and fish oils on blood sugar and insulin levels in polycystic ovary syndrome (PCOS) patients. The hypothesis is that a diet rich in these foods will improve insulin resistance in women with PCOS.

Polycystic ovary syndrome is a common disease that affects 1 out of 16 women. Metabolic and endocrine abnormalities seen in PCOS include insulin resistance, androgen excess and infertility. This study focuses on the insulin resistance aspect because increased insulin resistance leads to premature onset of impaired glucose tolerance or diabetes whereas decreased insulin resistance reduces androgen excess, improves the ovarian function and increases fertility. Although insulin resistance can be treated with insulin-sensitizing drugs, PCOS clinically manifests during adolescence and the long-term safety of the drug-treatment can be a concern. Thus, improving insulin resistance with effective nutritional approaches would be very desirable. Epidemiological studies and animal experiments suggest that replacement of dietary saturated fats with monounsaturated (MUFA) and polyunsaturated (PUFA) fats improves insulin resistance.

The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome

Walnuts, Walnut-Oil, Glucose Homeostasis, PCOS

National Institutes of Health (NIH)

National Center for Complementary and Integrative Health (NCCIH)

University of California, Davis

Obesity

Metformin

Metformin 850mg twice a day for six months

Magnesium chloride 250mg daily for six months

Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) 1.1mg daily for six months

Intervention also includes weight reduction diet and exercise therapy

Magnesium

PUFA

Mardia Guadalupe López Alarcón, MD, phD

Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in reproductive age women. PCOS is usually characterized by an excessive androgen production, menstrual irregularities, and polycystic ovaries. Women with PCOS are often obese and have a varying degree of insulin resistance (IR). Weight reduction constitutes the initial treatment for these patients. Metformin has proven to be useful in IR and is frequently used in PCOS. However metformin use may be accompanied by gastrointestinal discomfort, and a high abandon rate. Other therapeutic alternatives such as magnesium and polyunsaturated fatty acids have been used in other IR states and may be useful in PCOS. The aim of this study is to asses the efficacy of these alternatives in obese PCOS patients.

The study is open label. No blindness for participant or investigator is used

Omega 3 Polyunsaturated Fatty Acids (PUFA) or Magnesium in Obese Polycystic Ovary Syndrome Patients

Effect Polyunsaturated Fatty Acids or Magnesium in Metabolic, Hormonal, and Inflammatory Profile in Obese Women With Polycystic Ovary Syndrome. A Randomized Clinical Trial

Serum concentration of metabolic biomarkers (glucose, insulin, triglycerides, cholesterol, HDL, M and M/I value derived from a euglycemic clamp)

Serum concentration of hormones \[Testosterone, dehydroepiandrosterone sulphate (DHEAs), sex hormone-binding globulin (SHBG), free androgen index (FAI)\]

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
Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients	NCT00433797	Prostate Cancer	Prostate cancer...	-	University of Oslo
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
The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome	NCT00579904	Polycystic Ovar... Insulin Resista...	walnuts almonds	18 Years - 45 Years	University of California, Davis
Omega 3 Polyunsaturated Fatty Acids (PUFA) or Magnesium in Obese Polycystic Ovary Syndrome Patients	NCT02521753	Polycystic Ovar... Obesity	Metformin Magnesium PUFA	18 Years - 38 Years	Coordinación de Investigación en Salud, Mexico
The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome	NCT00579904	Polycystic Ovar... Insulin Resista...	walnuts almonds	18 Years - 45 Years	University of California, Davis
The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome	NCT00579904	Polycystic Ovar... Insulin Resista...	walnuts almonds	18 Years - 45 Years	University of California, Davis
The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome	NCT00579904	Polycystic Ovar... Insulin Resista...	walnuts almonds	18 Years - 45 Years	University of California, Davis

Spots Global Cancer Trial Database for pufa

Every month we try and update this database with for pufa 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 pufa

Every month we try and update this database with for pufa 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 pufa 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.