Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

The Low carbohydrate arm will receive counseling to follow a carbohydrate restriction diet (\<20 grams per day) for 6 months.

The control arm will receive no dietary intervention.

The Low carbohydrate diet intervention recommends patients to limit carbohydrate intake to less than 20 gram per day.

Low carbohydrate diet

Pao-Hwa Lin

No treatments have been shown to slow prostate cancer progression after radical prostatectomy. We hypothesize that a carbohydrate restricted diet will slow prostate cancer growth. A total of 60 men with a rising prostate-specific antigen (PSA) after failed primary treatment will be recruited and randomized to either a low-carbohydrate diet (\<20 grams carbohydrates/day) or a no-diet control (standard of care) for 6 months. The primary outcome is PSA doubling time.

Carbohydrate Restriction and Prostate Cancer Growth

A Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men With A Rising PSA After Failed Primary Therapy for Prostate Cancer

PSA doubling time will be estimated from PSA measured at baseline, 3 and 6 months post randomization.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Robert C. Atkins Foundation

Cedars-Sinai Medical Center

Durham VA Medical Center

Duke University

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

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

Symptoms and General Pathology

Nervous System Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Recurrence

Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Ketosis

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Metformin

Biguanides

Partial brain re-irradiation combined with metabolic intervention (low carbohydrate diet and/or metformin treatment)

Partial brain re-irradiation to a dose of 30-35Gy delivered over 2 weeks (10 fractions).

Partial brain re-irradiation.

Different cohorts will receive no, low dose or higher dose metformin.

Under close supervision of a dietician, patients will receive a low carbohydrate diet, enriched as necessary with medium chain triglyceride (MCT) supplements.

low carbohydrate diet

Yaacov R Lawrence, MBBS MA MRCP

Hila Gnessin, Bsc

Yaacov R Lawrence, MA MBBS MRCP

Recurrent brain tumours are extremely aggressive and despite optimal treatment, median survival is less than two years. One of the standard treatment options in this situation is radiation therapy. Currently there is intense scientific interest concerning the abnormal energy metabolism in cancer cells. All cells require energy in order to function, obtaining 'fuel' molecules such as glucose and fatty acids from the blood stream. Brain tumours exhibit "metabolic reprogramming", meaning that their energy requirements and utilization of fuel molecules are quite different from normal cells. Brain tumour cells are exquisitely dependant on glucose as a source of energy. Animal studies have shown that when these tumours are deprived of glucose they are very sensitive to radiation therapy.

In this clinical trial the investigators combine radiation therapy with a low-carbohydrate diet, in patients with recurrent brain tumours. In addition, subjects will receive medication with metformin, a drug usually used to treat diabetes. Metformin inhibits glucose metabolism within cancer cells, and additionally has reported intrinsic anti-cancer activity. Subjects will undergo advanced imaging and hormonal studies before, during and after the trial in order to obtain maximal translational-scientific impact.

The hypothesis:

The metabolic changes induced by the combination of a moderately-low carbohydrate diet combined with supplementary MCT and metformin therapy will selectively starve tumor cells. While normal brain cells are capable of deriving energy from ketone bodies during glucose restriction, tumor cells remain largely glucose-dependent for energy due to oncogene induced down-regulation of oxidative phosphorylation. While the tumor cells are in this 'vulnerable' state they will be less able to repair the damage induced by ionizing radiation.

Short-term implementation of the metabolic intervention (i.e. combined diet and metformin therapy) prior to, during, and after hypofractionated (2 week) radiation therapy is expected to increase tolerability, increase compliance and avoid the chronic metabolic complications associated with extreme carbohydrate restriction diets.

Treatment of Recurrent Brain Tumors: Metabolic Manipulation Combined With Radiotherapy

Improving the Response of Recurrent Glioma to Radiation Therapy Through Metabolic Intervention

The investigators will track adverse events in order to determine the safety of the intervention.

We will track patient compliance in order to determine the tolerability of the intervention.

We will assess plasma levels of glucose, insulin and other relevant hormones before, during and after the intervention.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carbohydrate Restriction and Prostate Cancer Growth	NCT01763944	Prostate Cancer	Low carbohydrat...	20 Years -	Duke University
Carbohydrate Restriction and Prostate Cancer Growth	NCT01763944	Prostate Cancer	Low carbohydrat...	20 Years -	Duke University
Comparison of Healthy Diets on Breast Cancer Markers	NCT02744079	Breast Neoplasm...	Low carbohydrat... Low fat diet	21 Years -	Albert Einstein College of Medicine
Comparison of Healthy Diets on Breast Cancer Markers	NCT02744079	Breast Neoplasm...	Low carbohydrat... Low fat diet	21 Years -	Albert Einstein College of Medicine
Treatment of Recurrent Brain Tumors: Metabolic Manipulation Combined With Radiotherapy	NCT02149459	Brain Neoplasms	Partial brain r... Metformin low carbohydrat...	18 Years -	Sheba Medical Center

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