Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) approximately, some sample meals are described in appendix 1) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.

Pazopanib

Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal.

Low Fat Diet

Ajjai Alva, M.D.

Pazopanib is an orally administered multi-kinase inhibitor targeting VEGFR (vascular endothelial growth factor receptor), PDGFR (platelet derived growth factor) and c-kit, which are critical to growth and proliferation of neoplastic cells. Pazopanib has been FDA approved for advanced renal cell carcinoma (RCC) with a clear cell component. Conventional Pazopanib dosing WITHOUT FOOD is with an initial dose of 800 mg by mouth daily. Investigators hypothesize that administration of pazopanib with low fat meal would be safe and feasible with secondary implications of higher pazopanib levels; potentially translating into greater anti-tumor efficacy in advanced renal cell cancer, with significant cost savings. In the proposed pilot study, investigators seek to test the feasibility and practicality of this approach and gather preliminary data on adverse effects and the safety profile. Investigators hope to ameliorate any potential for greater toxicities with a dynamic dosing design that incorporates adverse events from each cycle into dosing for the next cycle and a structured symptom specific plan.

Pilot Study of Pazopanib With Low Fat Meal (PALM) in Advanced Renal Cell Carcinoma

Number of grade 3 or 4 adverse events associated with pazopanib administered with a low fat meal by CTCAE version 4.0.

The median duration of treatment will be reported.

To estimate the overall response proportion to pazopanib administered with a low fat meal by RECIST 1.1 criteria. Overall response is defined as the number patients that experience Partial Response (PR) or Complete Response (CR).

CR is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.

PR is defined as At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.

Complete response is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.

Partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.

University of Michigan Rogel Cancer Center

Adverse Events (AEs) were collected beginning at treatment start through 30 days post last treatment administration.

Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Baseline ECOG performance status. ECOG stands for Eastern Cooperative Oncology Group. The performance status is scale used by doctors and researchers to assess how the disease affects the daily living abilities of the patient.The scale ranges from 0 to 5 where 0 represents perfect health and 5 represents death.

0=Fully active, able to carry on all pre-disease performance without restriction

1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work

Baseline Performance Status

Renal cell carcinoma cellular histology at baseline.

Histology

Lung

Adrenal

Pancreas

Liver

Bone

Nephrectomy bed

Retroperitoneal and perisplenic nodule

Sites of renal cell carcinoma metastasis at baseline.

Baseline Disease Site

The Heng Score for Metastatic Renal Cell Carcinoma (RCC) prognosis determines overall survival in patients treated with VEGF-targeted therapy using a scoring system that assigned points based off of a number of criteria.

Score interpretation:

0=Favorable 1-2=Intermediate

≥3=Poor

Heng Criteria Score

Number of Prior Therapies

Everolimus

High-dose IL-2

Sunitinib

Nivolumab

Prior Therapy Type

Sixteen patients were enrolled in this study; three patients withdrew study consent prior to study completion.

Dr. Ajjai Alva, M.D.

Grade 3 adverse events associated with treatment

Grade 4 adverse events associated with treatment

16 participants were enrolled and treated.

Number of Grade 3 or 4 Adverse Events

16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.

Number of Participants With Dose Reductions

Duration of Treatment

Median Total Dose

Percentage of Patients That Respond to Treatment (Overall Response) With Pazopanib Administered Along With a Low Fat Diet

Number of Participants With Complete Response

Number of Patients With Partial Response

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

45 subjects will receive a very low carbohydrate diet between a positive breast biopsy and surgical tumor removal

20 subjects will receive a lo fat diet between a positive breast biopsy and surgical tumor removal

45 subjects will be randomized to a dietary arm consisting of a complete, prepared very low carbohydrate diet, delivered to their homes, for the interval between positive breast biopsy and surgical tumor removal

Low carbohydrate diet

20 subjects will be randomized to a dietary arm consisting of a complete, prepared low fat diet, delivered to their homes, for the interval between positive breast biopsy and surgical tumor removal.

Low fat diet

Eugene J Fine, MD

Women post breast mass biopsy with ER+or ER- cancer will be randomized to two diets--goal of 45 of them to a ketogenic insulin inhibiting diet, 20 to a low fat diet with whole grains and fruits and vegetables. The initial biopsy will be evaluated along with the surgical specimen pathology to compare changes in biomarkers, particularly of proliferation (Ki-67) and apoptosis (TUNEL).

A healthy diet has been defined in various ways. The investigators wish to compare the effects of two diets on ER positive breast cancer tissues. The diets will be administered between the time of diagnosis and the time of surgical removal. Both diets have been proposed as healthy, but differ in their composition. One constitutes a low fat diet with extra fiber, fruits and vegetable servings, while the other comprises a diet low in carbohydrate content, aiming to lower insulin secretion. Patients will be randomized to each group, with 20 assigned to the low fat arm and 45 to the low carbohydrate arm.

Comparison of Healthy Diets on Breast Cancer Markers

A Pilot Presurgical Trial of Insulin Inhibition by a Ketogenic Diet in Operable Breast Cancer

Albert Einstein College of Medicine

Professor of Radiology

Other Dietary Supplements

Hormones

Omega 3 Fatty Acid

Low Fat diet

Low Fat high n3 diet

High Fat Diet

Susan K Raatz, PhD, RD

The primary objective of this investigation is to determine whether diets designed to increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid enrichment), will favorably affect sex hormone distribution in women in a direction associated with reduced risk of sex hormone-mediated cancer development. Specifically, we hypothesize that an increased concentration of circulating n3 fatty acids will reduce the biochemical markers associated with increased risk for developing certain sex hormone mediated cancers such as breast cancer

The guiding concept of our proposal is that both the total fat and the fatty acid composition of the diet contribute to a milieu associated with the risk for sex-hormone mediated cancers. Specifically, we hypothesize that an increased concentration of circulating n3 fatty acids will reduce the biochemical markers associated with increased risk for developing certain sex hormone mediated cancers such as breast cancer. When compared with the high fat diet, we expect n3 concentrations to increase and sex hormone levels to decrease after both low fat and low fat/n3 rich diets, with the greatest response in the low fat-n3 supplemented group. The aims of this project are: 1) to evaluate the effects of total fat and n3 fatty acid consumption on plasma and urine sex hormone concentrations in postmenopausal women, 2) to evaluate the relationship between plasma concentrations of fatty acids and plasma and urinary sex hormone concentrations, and 3) to evaluate the effects of total fat and n3 fatty acid consumption on the associations between sex hormone concentrations and urinary prostaglandin E2 and thromboxane B2 concentrations.

The primary objective of this investigation is to determine whether diets designed to increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid enrichment), will favorably affect sex hormone distribution in women in a direction associated with reduced risk of sex hormone-mediated cancer development. The primary endpoints to be evaluated include plasma and urinary sex hormone concentrations as follows:

Endpoints associates with increased risk factors for breast cancer risk: plasma estradiol (E2), estrone (E1), estrone sulfate (E1 sulfate), testosterone, androstenedione, sex hormone binding globulin (SHBG), dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEAS), Measures of estrogen action: plasma follicle stimulating hormone (FSH), urinary estrogen metabolites.

Measures of systemic arachidonic acid-derived eicosanoids: urinary bicyclo-prostaglandin E2 (PGEa), 2,3-dinor thromboxane B2 (TXB2).

Measures reflecting influence of dietary fat and fatty acid intake: plasma phospholipid, cholesterol ester, triglyceride and free fatty acid composition.

Dietary Fat, Eicosanoids and Breast Cancer Risk

USDA Grand Forks Human Nutrition Research Center

Low Fat, High n3 Diet

Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3

Low Fat, High Fat, Low Fat High Omega 3

Low Fat, Low Fat High Omega 3, High Fat

High Fat, Low Fat, Low Fat High Omega 3

High Fat, Low Fat High Omega 3, Low Fat

Low Fat High Omega 3, High Fat, Low Fat

Low Fat High Omega 3, Low Fat, High Fat

Total

Age, Categorical

United States

Region of Enrollment

Susan Raatz, PhD, RD

Plasma Sex Hormone Levels

1st Intervention (8 Weeks)

Washout (8 Weeks)

2nd Intervention (8 Weeks)

3rd Intervention (8 Weeks)

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Heart and Blood Diseases

Nervous System Diseases

Diabetes Mellitus

Syndrome

Cognitive Dysfunction

Coronary Artery Disease

Coronary Disease

Myocardial Infarction

Infarction

Neoplasm Metastasis

Metabolic Syndrome

Angina Pectoris

Angina, Unstable

Ischemia

Necrosis

Myocardial Ischemia

Heart Diseases

Vascular Diseases

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Pain

Chest Pain

Neurologic Manifestations

Herbal and Botanical

Olive

Dietary Intervention with a Low fat diet: \<30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; \<10% saturated fatty acids)

Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; \<10% saturated fatty acids).

Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; \<10% SAT).

Mediterranean Diet

Low fat diet: \<30% fat (12% MUFA; 6-8%PUFA; \<10% SAT)

Francisco Perez-Jimenez, MD,PhD

The purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular events of persons with coronary disease.

Randomized clinical trial involving 1002 patients with coronary disease that are undergoing one of two diets in a randomized design (two groups; Mediterranean Diet 502 patients, Low Fat 500 patients) for 7 years. The two diets are: a)Low fat diet: \<30% fat (12-14% monounsaturated fatty acids (MUFA); 6-8% polyunsaturated fatty acid (PUFA) ; \<10% SAT) and b) Mediterranean Diet: \>35% fat (22% MUFA; 6% PUFA ; \<10% SAT).

Primary Objective:

Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death).

Secondary Objectives:

Those related in the Outcome Measures section of this webpage

CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention

Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease

Endothelium response to ischemia in the brachial artery. Area under the curve, flow peak and time to maximum flow will be performed

Influence of genetic data in the development clinical outcomes

Postprandial lipemia study based on oral fat tolerance test depending on clinical and genetic variables

Clinical events not qualifying as primary endpoint nor in the secondary objectives 1 and 2, especially those associated with cardiovascular disease

Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function

Additional secondary objectives will be carried out in light of current and/or future knowledge of ischemic heart disease risk factors, prognostic factors and pathophysiological pathways, and will include, but not be limited to, endothelial function, inflammation, cell biology, molecular biology, proteomics, genetics and epigenetics

Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years.

Data from clinical and/or diagnostic tests will be analyzed

Concentration of LDL cholesterol in blood samples

Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study

Study of the metabolism of carbohydrates during the trial

Study of blood pressure in response to the study

Cognitive decline will be evaluated by validated questionnaires

Incidence of cardiac death, myocardial infarction, angina event, coronary revascularization or cardiac transplant, stroke, symptomatic heart failure, or any other clinical manifestation of cardiovascular event.

Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest

Incidence of type 2 Diabetes Mellitus during the study

Clinical features of metabolic disease: Metabolic Syndrome, Metabolic Phenotypes of Obesity or other classifications based on anthropometric features will be assessed during the study

Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events.

Study of relationship between existing or new Arrhythmias on clinical events

Individual apparition of hard cardiovascular events:

* myocardial infarction
* revascularization
* ischemic stroke
* documented peripheral artery disease
* cardiovascular death

Global metabolomics in plasma, as well as techniques targeting specific sets of metabolites such as lipid-based lipid species, protein by proteomics, etc.

Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc

Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc

Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied

Metabolism of advanced glycation end products.

Impact of mineral metabolism on atherosclerosis

Cardiac function studies by Echocardiography at baseline and during the study

Study of endothelial microparticles (vesicles formed from endothelial cells membrane after injury). The quantification of the EPCs and EMPs will be performed by flow cytometry

27. Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Study of Pazopanib With Low Fat Meal (PALM) in Advanced Renal Cell Carcinoma	NCT02729194	Carcinoma, Rena...	Pazopanib Low Fat Diet	18 Years -	University of Michigan Rogel Cancer Center
Comparison of Healthy Diets on Breast Cancer Markers	NCT02744079	Breast Neoplasm...	Low carbohydrat... Low fat diet	21 Years -	Albert Einstein College of Medicine
Dietary Fat, Eicosanoids and Breast Cancer Risk	NCT01824498	Breast Cancer	Low Fat diet Low Fat high n3... High Fat Diet	40 Years - 70 Years	USDA Grand Forks Human Nutrition Research Center
CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention	NCT00924937	Myocardial Infa... Unstable Angina Malignancy Cognitive Decli... Diabetes Mellit... Metabolic Syndr...	Mediterranean D... Low Fat Diet	20 Years - 75 Years	Hospital Universitario Reina Sofia de Cordoba
Comparison of Healthy Diets on Breast Cancer Markers	NCT02744079	Breast Neoplasm...	Low carbohydrat... Low fat diet	21 Years -	Albert Einstein College of Medicine

Spots Global Cancer Trial Database for low fat diet

Every month we try and update this database with for low fat diet 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.