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Omega 3 Fatty Acid

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

Inflammation

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.

Smartfish AS

Per Kogner

Professor

Behaviors and Mental Disorders

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Participants will be asked to take four 400 mg (1600 mg; 1.6 grams) capsules of DHA daily. Participants will start taking capsules before the start of and for the duration of their neoadjuvant chemotherapy.

Participants will be asked to take four 400 mg (1600 mg; 1.6 grams) capsules of a matched placebo daily. Participants will start taking capsules before the start of and for the duration of their neoadjuvant chemotherapy.

Placebo

The purpose of this study is to determine if a high dose of DHA begun prior to and continued during neo-adjuvant chemotherapy (chemotherapy given prior to surgery) is likely to prevent or lessen chemotherapy induced cognitive dysfunction.

Chemotherapy is often associated with problems of cognitive functioning such as decision making, learning, and memory. These symptoms, collectively referred to here as cognitive dysfunction can appear as early as the first few months after starting chemotherapy and may persist long after chemotherapy and anti-hormone therapy, if any, is completed.

Once developed there is no satisfactory treatment for cognitive dysfunction although cognitive retraining and exercise may improve symptoms and/or function; at least for some.

Omega-3 fatty acids derived from ocean fish are a new potential preventative treatment against development of cognitive problems which can arise in some individuals during chemotherapy treatment. In doses of 1-2 grams per day it has been found to improve some aspects of cognitive function in healthy adults who have low DHA dietary intake. It has also been shown to improve some aspects of function in individuals with a mild reduction in cognitive ability but not for those with marked impairment.

Participation in this study will last about 12 months. Participants will make visits to the study site for both standard of care visits and additional study-related visits. Participants will be randomized (randomly assigned; like flipping a coin) to one of two groups. Neither the Investigator nor the participant will know the assigned treatment.

Docosahexaenoic Acid (DHA) To Prevent Development of Cognitive Dysfunction Due to Chemotherapy

Number of potentially eligible subjects who consent to participate in the study.

Number of enrolled subjects who complete all cognitive assessments at all three defined timepoints.

Number of enrolled subjects who take at least 70% of prescribed study agent.

Number of enrolled subjects randomized to DHA who report serious adverse events (adjusted for subjects randomized to placebo who report serious adverse events).

Change measured using Patient-Reported Outcomes Measurement Information System (PROMIS-General Concerns). There are a total of 34 questions. Each question has five response options ranging in value from one to five (never to very often). The total score is based on the sum of the responses, multiplied by the number of questions and then divided by the number of questions that were answered.

Change measured using Patient-Reported Outcomes Measurement Information System (PROMIS-Abilities). There are a total of 33 questions. Each question has five response options ranging in value from one to five (never to very often). The total score is based on the sum of the responses, multiplied by the number of questions and then divided by the number of questions that were answered.

Change measured using Patient-Reported Outcomes Measurement Information System (PROMIS 29-Profile). The PROMIS 29-Profile includes 4 items from 7 different domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities, along with a single item on pain intensity). The total score is based on the sum of the responses, multiplied by the number of questions and then divided by the number of questions that were answered.

Physical activity will be tracked over course of the study. Participants will complete a physical activity questionnaire (PAQ-4) at each visit.

Change measured based on standard battery of cognitive tests including Hopkins Verbal Learning Test-Revised, Trail Making A, Trail Making B and Controlled Oral Word Association.

The MCAB measures working memory, divided attention/multitasking, cognitive flexibility and processing speed and also includes a 33 item self-rating questionnaire that assesses everyday cognitive behaviors, physical activity, sleep, pain and functional adjustment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
OmegaChild - Omega-3 Supplementation to Children Previously Treated for Cancer	NCT02134600	Pediatric Cance...	Omega-3 enriche...	2 Years - 18 Years	Karolinska Institutet
Docosahexaenoic Acid (DHA) To Prevent Development of Cognitive Dysfunction Due to Chemotherapy	NCT02517502	Cognitive Dysfu...	DHA Placebo	18 Years - 65 Years	University of Kansas Medical Center

Spots Global Cancer Trial Database for dha

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

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