Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Malnutrition

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Nutrition Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Other Dietary Supplements

All Drugs and Chemicals

Omega 3 Fatty Acid

This group will be receive the DHA supplement

Children will be received either fish oil capsules (DHA group) or placebo capsules (placebo group) which is visually indistinguishable from DHA capsules (softgel). Each child will be receiving 100 mg/kg/day or placebo capsules without docosahexaenoic acid, during the first three months of treatment.

Docosahexaenoic acid (DHA)

Placebo

Maria de Lourdes Barbosa-Cortes, MSc

The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration during the first three months of treatment reduces the deterioration of nutritional status, treatment toxicity and early mortality in children with acute lymphoblastic leukemia.

Cancer is often associated with malnutrition.The most of children with cancer loss weight, and 50-80% of patients with cancer experience morbidity and mortality as a result of progressive wasting.

As a consequence of malnutrition, patients with cancer may have a poorer outcome, reduced effectiveness of chemotherapy and increased risk of chemotherapy-induced toxicity compared to those who are well nourished at diagnosis. On the other hand, in the recent years, there has been increased focus on the role of long chain polyunsaturated fatty acids and their effect on prevention and treatment of several diseases. The results of animal studies and adults with cancer have demonstrated that the consumption of long chain polyunsaturated fatty acids can slow the growth of cancer, increase the efficacy of chemotherapy and reduce loss weight and the side effects of the chemotherapy.

Beneficial effects of enteral long chain polyunsaturated fatty acids has been reported in adults with cancer. However, in children with cancer the scientific reports are scarce; therefore, is necessary to evaluate if the long chain polyunsaturated fatty acids administration in children with acute lymphoblastic leukemia has the same effects on clinical and nutritional outcomes that have been previously showed by different studies in adults with cancer.

Effect of Enteral Docosahexaenoic Acid Administration in Children With Acute Lymphoblastic Leukemia

The Effect of Enteral Administration of Polyunsaturated Omega-3 Fatty Acids on Nutritional Status; the Treatment Toxicity and Early Mortality in Children With Acute Lymphoblastic Leukemia - a Controlled Study

National Council of Science and Technology, Mexico

Instituto Mexicano del Seguro Social

Coordinación de Investigación en Salud, Mexico

Associated Researcher

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Inflammation

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

The patients diagnosed as PCOS according to Rotterdam criteria will be the study group. The DHA leves in blood sample of the patients will be recorded

The patients without PCOS will be control group. The DHA leves in blood sample of the patients will be recorded

DHA levels of blood and cervical mucus of the control and the study groups will be measure

DHA levels of blood and cervical mucus

MEHMET KAGITCI

Although PCOS has been known for many years, its etiology and treatment are not clearly known. The prevalence of PCOS varies between populations. It is a familial endocrinolpathology with a chronic course, multifactorial, polygenic feature seen with an average prevalence of 6-8% in women in the reproductive period.Chronic inflammation is involved in the pathophysiology of many chronic diseases. PCOS, which is a proinflammatory condition, has been associated with insulin resistance and hyperandrogenism in previous studies.

Omega-3 fatty acids have anti-inflammatory, anti-thrombotic, anti-arrhythmic properties, reducing lipid levels such as serum triglyceride and LDL cholesterol, and having positive effects on the immune system. Therefore, their deficiencies include fatigue, joint pain, frequent infections, etc. is seen. Omega-6 fatty acids have the opposite effect.

DHA is a member of the omega-3 fatty acids family. Dietary components play an important role in chronic inflammation.

According to our literature review, there is no study that detects docosahexaenoic acid (DHA) levels in blood and cervical mucus samples in patients with PCOS. We think that we will contribute to the diagnosis and treatment processes of PCOS patients by detecting DHA levels in this study.

In this study, we aim to compare the values of docosahexaenoic acid (DHA) in serum and cervical mucus samples in patients with polycystic ovary syndrome with the control group.

Polycystic ovary syndrome (PCOS) was first described in 1935 by Dr. Stein and Dr. It was defined by Leventhal. Although PCOS has been known for many years, its etiology and treatment are not clearly known. The prevalence of PCOS varies between populations. It is a familial endocrinolpathology with a chronic course, multifactorial, and polygenic features, with an average prevalence of 6-8% in women in the reproductive period. PCOS is a symptom complex that requires a multidisciplinary approach involving many departments. The clinic in PCOS progresses with different symptoms in each patient. In general, such as menstrual irregularities, alopecia due to androgen excess, acne, hirsutism, infertility, obesity, abnormal lipid levels, glucose intolerance, acanthosis nigricans, Type 2 diabetes, endometrial hyperplasia, endometrial cancer, ovarian cancer, breast cancer, hypertension, coronary heart diseases. It progresses with mood changes ,cardiovascular diseases, abortion, IUGR, depression, anxiety, eating disorders, and obstructive sleep apnea. Determining the diagnostic criteria for PCOS is important in terms of long-term risks rather than short-term effects in patients. PCOS diagnostic criteria were divided into different categories in 3 different periods. For the first time, 3 important criteria were determined in the National Institutes of Health Criteria (NICHD) in 1990. (1)menstrual dysfunction (oligo/anovulation), (2) hyperandrogenism/hyperandrogenemia (hirsutism, acne, androgenetic alopecia), (3) causes mimicking similar clinics should be excluded. Rotterdam Consensus Criteria was determined in 2003 for the second time in the diagnosis of PCOS. Rotterdam Criteria At least 2 of the 3 major criteria must be present. The first criterion is (1) menstrual dysfunction (oligo/anovulation), (2) hyperandrogenism/hyperandrogenemia (hirsutism, acne, androgenetic alopecia), (3) polycystic ovarian morphology in ultrasonography (at least one ovary with 12 or more follicles 2-9 mm in diameter) and ovarian volume of 10 ml or more) and similar clinical mimicking causes should be excluded. Third are the Androgen Excess Society (AE-PCOS) criteria made in 2006. The criteria should be (1) menstrual dysfunction (oligo/anovulation), (2) hyperandrogenism/hyperandrogenemia (hirsutism, acne, androgenetic alopecia), (3) polycystic ovary appearance on ultrasonography, and (a) causes mimicking similar clinics. 1 and 2 or 2 and 3 conditions were determined from these criteria.

Chronic inflammation is involved in the pathophysiology of many chronic diseases. PCOS, which is a proinflammatory condition, has been associated with insulin resistance and hyperandrogenism in previous studies.

All fats play important roles in energy metabolism and body functions; however, the omega-6 precursor, linoleic acid (LA), and the omega-3 precursor, alpha-linolenic acid (ALA), are known as essential fatty acids because they cannot be synthesized in the body and therefore become a vital component of a healthy diet. These are unsaturated fatty acids with double bonds between carbon atoms, unlike saturated fatty acids, where all carbon atoms are "saturated" with hydrogen atoms. Depending on the position of the double bond with respect to the methyl end carbon (omega carbon), unsaturated fatty acids are classified as omega-3 and omega-6 fatty acids. Omega-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) contain alpha- it is derived from linolenic acid (ALA) .

Omega-3 fatty acids have anti-inflammatory, anti-thrombotic, anti-arrhythmic properties, reducing lipid levels such as serum triglyceride and LDL cholesterol, and having positive effects on the immune system. Therefore, their deficiencies include fatigue, joint pain, frequent infections, etc. is seen. Omega-6 fatty acids have the opposite effect.

DHA is a member of the omega-3 fatty acids family. Dietary components play an important role in chronic inflammation. It has been reported that a diet rich in omega-3 fatty acids may have positive effects on epigenomes. It has been shown that inflammatory cytokines such as interleukin 1-β, thromboxane A2, interleukin-6, tumor necrosis factor, leukotriene B and C-reactive protein increase in chronic diseases. In particular, the anti-inflammatory effects of omega-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have been reported.

There are studies showing that some inflammatory substances in the endometrial washings of PCOS patients are different from the normal population . These studies suggest that inflammation may also be a cause of common infertility in PCOS patients by affecting endometrial receptivity.

According to our literature review, there is no study that detects docosahexaenoic acid (DHA) levels in blood and cervical mucus samples in patients with PCOS. We think that we will contribute to the diagnosis and treatment processes of PCOS patients by detecting DHA levels in this study.

In this study, we aim to compare the values of docosahexaenoic acid (DHA) in serum and cervical mucus samples in patients with polycystic ovary syndrome with the control group.

Comparison of Docosahexaenoic (DHA) Values in Patients With Polycystic Ovary Syndrome (PCOS)

Comparison of Docosahexaenoic Acid (DHA) Serum and Cervical Mucus Sample Values in Patients With Polycystic Ovary Syndrome (PCOS) and Control Group

Cervical mucus DHA levels of patients with PCOS

Recep Tayyip Erdogan University Training and Research Hospital

Assistant professor

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

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Carcinoma in Situ

Carcinoma, Lobular

Breast Carcinoma In Situ

Precancerous Conditions

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Breast Diseases

Fibrocystic Breast Disease

Paget's Disease, Mammary

Carcinoma, Ductal

Neoplasms, Glandular and Epithelial

Skin Diseases

Adenocarcinoma

Paget Disease of the Breast

Docosahexaenoic Acid orally twice a day (PO BID) for 12 weeks.

Placebo orally twice a day (PO BID) for 12 weeks.

Docosahexaenoic Acid

Ayca Gucalp

Powel H. Brown, MD

This randomized phase II trial studies how well docosahexaenoic acid works in preventing recurrence in breast cancer survivors. Docosahexaenoic acid supplement may prevent recurrence in breast cancer survivors.

PRIMARY OBJECTIVES:

I. To determine whether treatment with docosahexaenoic acid (DHA) for 12 weeks at 1000 mg twice daily as compared to placebo reduces normal breast tissue levels of tumor necrosis factor-alpha (TNF-alpha) in overweight and obese patients with a history of stage I-III invasive breast cancer, ductal carcinoma in situ (DCIS), Paget's disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease.

SECONDARY OBJECTIVES:

I. To investigate the effect of DHA at 1000 mg twice daily on tissue biomarkers

* Change from the baseline in cyclooxygenase-2 (COX-2)/interleukin-1-beta (IL-1beta)/aromatase measured by quantitative real-time polymerase chain reaction (PCR).
* Change from the baseline in crown-like structures of the breast (CLS-B) measured by immunohistochemical techniques for cluster of differentiation (CD)68.
* Change from baseline in CLS-B index determined as follows: (\[number of slides with evidence of at least one CLS-B\]/\[total number of slides examined\]).
* Change from baseline in CLS-B/cm\^2 defined as the number of CLS-B/cm\^2. II. Evaluate age as a predictor of CLS-B and inflammatory biomarkers (TNF-alpha/COX-2/IL-1beta) at baseline and over the time of treatment.

III. Evaluate red blood cell (RBC) fatty acid level as a surrogate of compliance.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive docosahexaenoic acid orally (PO) twice daily (BID) for 12 weeks.

ARM II: Patients receive placebo PO BID for 12 weeks.

Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors

A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients With a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease

Differences in normal breast tissue levels of TNF-α 12 weeks post-treatment relative to pre-treatment for active treatment and placebo arm, compared using analysis of covariance where the post-treatment measurements were used as a dependent variable and the pretreatment measurements were included as a covariate in the analysis. For the primary study end-point TNF-α levels will be measured by quantitative real-time PCR (mRNA essays) on extracted RNA from breast core biopsies. Relative expression determined using the Computed Tomography (ΔΔCT) analysis protocol.

An indicator of whether a subject is detected with CLS-B or not.

To assess the severity of CLS-B using the following formula: number of CLS-B/cm\^2. The absolute change in the CLS-B/cm\^2 calculated according to the formula; Change in CLS-B/cm\^2 = (post-treatment CLS-B/cm\^2) - (pre-treatment CLS-B/cm\^2).

Biomarkers COX-2 are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis.

Biomarkers IL-1Beta are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis.

Biomarkers Aromatase are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis.

Whole blood samples collected for red blood cell fatty acid analyses at baseline and week 12 (+ 2 weeks). RBC fatty acid composition analyzed by gas chromatography (GC) with flame ionization detection.

National Cancer Institute (NCI)

Docosahexaenoic Acid 1000 mg orally twice a day for 12 weeks.

DHA 1000 mg orally twice a day for 12 weeks.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Powel H. Brown, MD/Chair, Clinical Cancer Prevention

Baseline

Post-Treatment

Post-treatment vs. Baseline Change

Docosahexaenoic Acid (DHA) 1000 mg orally twice a day for 12 weeks.

6 participants in the Placebo group and 1 participant in the DHA group were not evaluable due to tissue was not available quantitative RT-PCR.

Normal Breast Tissue Expression of Tumor Necrosis Factor Alpha (TNF-alpha) Levels

Post-treatment

Positive both Baseline and Post-treatment

4 participants on the placebo arm and 1 participant on the DHA arm did not have a post treatment biopsy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Enteral Docosahexaenoic Acid Administration in Children With Acute Lymphoblastic Leukemia	NCT01051154	Acute Lymphobla... Malnutrition	Docosahexaenoic... Placebo	4 Years - 15 Years	Coordinación de Investigación en Salud, Mexico
Comparison of Docosahexaenoic (DHA) Values in Patients With Polycystic Ovary Syndrome (PCOS)	NCT05597111	Polycystic Ovar...	DHA levels of b...	18 Years - 40 Years	Recep Tayyip Erdogan University Training and Research Hospital
OmegaChild - Omega-3 Supplementation to Children Previously Treated for Cancer	NCT02134600	Pediatric Cance...	Omega-3 enriche...	2 Years - 18 Years	Karolinska Institutet
Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors	NCT01849250	Benign Breast N... Ductal Breast C... Invasive Breast... Lobular Breast ... Paget Disease o... Stage IA Breast... Stage IB Breast... Stage IIA Breas... Stage IIB Breas... Stage IIIA Brea... Stage IIIB Brea... Stage IIIC Brea...	Docosahexaenoic... Placebo	18 Years -	National Cancer Institute (NCI)

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