Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

All Drugs and Chemicals

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day) + standard of care aromatase inhibitors

Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day)

Carbohydrate restricted dietary intervention

standard of care aromatase inhibitors

Monica Mita, MD

This is a feasibility trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via counseling with dietitian plus aromatase inhibitor therapy. Visits will occur at screening, mid-study, and pre-surgery. Anthropomorphic measurements, and patient reported outcomes (PROs) will be taken at all three visits. Patients will speak with a dietitian at their monthly standard of care visits, and will receive weekly calls for the first 4 weeks of the intervention. All subjects will receive surgery after approximately 6 months of intervention. Total duration of the study is expected to be 2 years, though each patient's participation will be approximately 6 months.

NEOBREADS: Neoadjuvant Breast Diet Study

IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study

Proportion of patients able to consistently adhere to the low carbohydrate diet in combination with AIs during neo-adjuvant treatment. The patient will be considered adherent for each food diary if \<20% of calories were obtained from carbohydrates. This will be approximately 80 grams of carbohydrates but will vary depending on total caloric intake. A patient will be considered adherent to the diet overall if they meet the adherence cutoff at least 75% of the time (i.e. in at least 75% of food diaries for a single patient \<20% of calories were obtained from carbohydrates).

Difference in change in tumor size between pre- and post-intervention between carbohydrate restricted and control group.

Change in Ki67 between pre-and post- intervention

Change in weight between pre- and post- intervention

Change in HbA1c between pre- and post- intervention

Change in insulin between pre- and post- intervention

Change in triglycerides between pre- and post- intervention

Change in LDL cholesterol between pre- and post- intervention

Change in HDL cholesterol between pre- and post- intervention

Change in total cholesterol between pre- and post- intervention

Cedars-Sinai Medical Center

Monica Mita

Professor, Medicine

Farin Amersi, MD

This is a randomized controlled trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via phone counseling with dietitian plus aromatase inhibitor therapy vs. 6-month control with aromatase inhibitor therapy alone. Visits will occur at screening, 3 months, and 6 months. Anthropomorphic measurements (such as heart rate, weight, and body measurement) and questionnaires will be taken at all three visits. After screening, patients will be randomized to receive the carbohydrate restricted diet coaching immediately (Arm A) or to a control group (Arm B). Patients randomized to Arm A will receive weekly calls for the first 3 months of the intervention, then biweekly calls for the last 3 months of the intervention from the study dietitian. Total duration of the study is expected to be 3 years, though each patient's participation will be approximately 6 months.

BREADS: Breast Adjuvant Diet Study

IIT2018-21-Amersi-BREADS BREADS: Breast Adjuvant Diet Study

Difference in change in weight between pre- and post- intervention between carbohydrate restricted and control group

Difference in changes in serum estradiol between pre- and post-intervention between low-carbohydrate group and control group

Difference in changes in fasting glucose between pre- and post-intervention between low-carbohydrate group and control group

Difference in changes in insulin between pre- and post-intervention between low-carbohydrate group and control group

Difference in changes in HbA1c between pre- and post-intervention between low-carbohydrate group and control group

Difference in changes in triglycerides between pre- and post-intervention between low-carbohydrate group and control group

Difference in changes in LDL between pre- and post-intervention between low-carbohydrate group and control group

Difference in changes in HDL between pre- and post-intervention between low-carbohydrate group and control group

Difference in changes in cholesterol between pre- and post-intervention between low-carbohydrate group and control group

Farin Amersi

Associate Professor, Surgery

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Adenocarcinoma

Weight Loss

Body Weight

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet.

Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian

Carbohydrate restricted diet

Non-restricted diet

Phone counseling with dietitian

Stephen Freedland, MD

This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI \>25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.

Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

Proliferative index is measured by Ki67/apoptosis rate

AUA intermediate risk is PSA \> 10ng/ml or grade group ≥ 2 or clinical stage ≥ T2b

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NEOBREADS: Neoadjuvant Breast Diet Study	NCT03822715	Breast Cancer	Carbohydrate re... standard of car...	18 Years -	Cedars-Sinai Medical Center
BREADS: Breast Adjuvant Diet Study	NCT04189263	Breast Cancer	Carbohydrate re... standard of car...	18 Years -	Cedars-Sinai Medical Center
Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance	NCT03679260	Prostate Cancer	Carbohydrate re... Non-restricted ... Phone counselin...	18 Years -	Cedars-Sinai Medical Center

Spots Global Cancer Trial Database for carbohydrate restricted diet