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

All Drugs and Chemicals

Micronutrients

Bone Density Conservation Agents

Dermatologic Agents

Herbal and Botanical

Vitamins

Calcium

Calcium, Dietary

Riboflavin

Phytoestrogens

Soy Bean

Vitamin B2

soy isoflavones: Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other innert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for upto 2 years.

isoflavones

carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other innert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for upto 2 years.

carbohydrate

Lee-Jane W Lu, Ph.D.

Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities, breast density and possibly bone density will be lower in women on soy-isoflavones.

This is a randomized, double-blind study, with two arms and 100 women in each arm. Premenopausal women will be recruited and randomly allocated to take one of the two different dietary supplements in pills daily for 2 years. The two supplements are soy isoflavones (treatment) and placebo (carbohydrates). Both treatment and placebo pills will contain multi-vitamins and minerals. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary supplement periods and analyzed for biomarkers of breast cancer risk. At baseline and after the intervention period, breast density and bone density will be assessed by radiologic techniques. The efficacy of the dietary intervention will be determined by comparing mean changes of serum markers for breast cancer risk,dense breast tissue, and bone mineral density over the two year dietary intervention period in the two supplement groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soy isoflavone supplement will reduce breast density, which may be explained by individual changes in serum markers of breast cancer risk.

One group received soy isoflavones (60 mg daidzein, 60 mg gensitein and 16.6 mg glycitein, all as aglycone equivalent) Another group, carbohydrate filler

Research pharmacist dispensed study pills according to a pre-generated randomization list and were blinded to all other aspects of the study protocol.

Subjects, research staff, investigators, and statistician all were blinded to treatment assignment.

Soy Isoflavones and Breast Cancer Risk Reduction

Mammographic Density and Soy Isoflavones

Effects of 1 and 2 years of treatment with isoflavones on percent of changes in FGBT%.

Area of FGBT in mammogram. The timepoints were combined and summed.

Bone mineral density of hip, spine and whole body bone mineral density as measured by dual x-ray absorptiometry. The timepoints were combined and summed.

National Center for Research Resources (NCRR)

The University of Texas Medical Branch, Galveston

Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other inert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for up to 2 years.

Soy Isoflavones

Carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other inert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for up to 2 years.

Placebo

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

One placebo and 4 isoflavone participants had missing or unsatisfactory baseline images.

FGBT%

Dr. Lee Jane W. Lu

(FGBT% at 1 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.

(FGBT% at 2 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.

Baseline

Year 1

Year 2

Subjects with at least 1 treatment image.

Fibroglandular Tissue in Total Breast (FGBT%)

Three Soy Isoflavones participants had missing mammograms.

Breast Density by Mammography

Hip bone mineral density

Spine bone mineral density

Whole body bone mineral density

Intention to treat participants. Two placebo and one isoflavone subjects had breast images but no DXA tests.

Bone Mineral Density

Enrollment/Allocation of Qualified Women

Follow-up <1 Year

Follow-up >1 to <2 Years

Follow-up 2 Years

Symptoms and General Pathology

Carcinoma

Postoperative Complications

Central Nervous System Depressants

Anesthetics

conventional preoperative fasting protocol The participants in the Fasting group stopped oral intake at 12:00 pm, the night before surgery. After surgery the participants fasted until the recovery of function of the bowel.

preoperative nutrition The participants of experimental group consumed 400 ml of a clear carbohydrate drink (12,5 gr/100 ml carbohydrate, 50 kcal/100 ml, pH 5.0) at 10:00 pm the evening before surgery and 200 ml of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.

The participants of experimental group consumed 400 ml of a clear carbohydrate drink (12,5 gr/100 ml carbohydrate, 50 kcal/100 ml, pH 5.0) at 10:00 pm the evening before surgery and 200 ml of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.

preoperative nutrition

Nermina Rizvanović, PhD

This study evaluated the impact of a preoperative carbohydrate oral drink on the postoperative Neutrophil / Lymphocyte Ratio (NLR) and the incidence of postoperative complications after elective open colon surgery compared to the conventional preoperative fasting protocol. Hypothesis was: preoperative carbohydrate loading reduces postoperative NLR value and reduces the incidence and severity of postoperative complications in colorectal surgery.

This prospective randomized, controlled clinical study was carried out in the Department of Anesthesiology and Intensive Care Unit and Department of Surgery at the Cantonal Hospital Zenica, Bosnia and Herzegovina. The study protocol was approved by the local Ethics Committee.

A total of 60 participants who scheduled for elective open colon surgery and fulfilled study criteria were included into study. The purpose and procedures of the study were fully explained and voluntary, informed, written consent was obtained from each participant. The participants were randomly allocated into two equal groups, depending on the preoperative treatment. There were no reliable published data for effects of preoperative carbohydrate loading on postoperative NLR values. Based on our hypothesis, a pilot study was performed with ten patients per group. Mean postoperative NLR value was 8,67±4,98 in the participants with a conventional preoperative fasting protocol versus 4,76±2,83 in the participants with preoperative carbohydrate loading. Sample size was estimated using sample size calculator software and power analysis with 95% confidence interval and power of 80%. Statistical significance was considered as p\< 0,05. The calculation indicated 27 participants per group would be sufficient to detect a difference of 3,91 with a standard deviation of 4,93 in NLR value between the groups. Assuming dropout of 10%, 30 participants per group were included. Block randomization was used with a block size of six and a 1:1 group ratio. A computer-generated random numbers indicating preoperative intervention, were sealed in opaque envelopes. An investigator who conducted randomization and opened the envelopes the night before surgery was blinded to the study protocol as well as the surgeons, nurses, anesthesiologists and staff involved in data collection.

The participants in the Fasting group (control group) stopped oral intake at 12:00 pm the night before surgery and underwent to a conventional preoperative fasting protocol. Participants in the Carbohydrate group (experimental group) consumed 400 ml of a clear carbohydrate solution at 10:00 pm the night before surgery and 200 ml of a clear carbohydrate solution, 2 hours prior induction of anesthesia. All participants underwent general anesthesia followed by colorectal surgery.

Fasting peripheral venous blood samples were collected at 06:00 am on the day of surgery (basal value), at 06:00 am on the first postoperative day, at 06:00 am on the third postoperative day and at 06:00 am on the fifth postoperative day. White blood counts were analysed with automated differential counts. The NLR value was obtained by dividing the absolute neutrophil count and the absolute lymphocyte count. All participants were followed up to 30 days post-surgery to assess postoperative complications and readmission rate. After discharge, participants were called by phone, once a week. Postoperative complications were graded for incidence and severity using the Clavien-Dindo Classification of Surgical Complications.

Demographic and surgical data of the participants were recorded: age, sex, body weight, body mass index, American Society of Anesthesiologists (ASA) physical status class, nutritional status of the participants according to Nutritional Risk Screening 2002 (NRS-2002), tumor localization and duration of surgery.

The patients with diagnosed colon cancer were hospitalized and prepared for elective, open colon surgery at the Department of Surgery. Before surgical procedure, the patients were undergoing to a preoperative anesthetic visit. During the visit, participants were assessed according to eligibility for enrollment in the study. The participants who have met the eligibility criteria have explained the nature of the study protocol. Those who agreed to participate in the study were randomized to one of two study groups for the duration of the study.

The surgeons, anesthetists, and outcome assessors were masking to the treatment allocation.

A nurse from the Department of Surgery performed the allocation into groups. The night before the operation, the nurse managed the patients according to the assigned intervention, but was not included in the study protocol. The next morning, the surgeon and anesthetist performed open elective colon surgery under general anesthesia, but without knowledge of the type of intervention.

Independent outcomes assessors evaluated patients up to 30 days post-surgery and were also masked, without knowledge of the type intervention.

Preoperative Administration of Oral Carbohydrate Drink, Neutrophil/Lymphocyte Ratio and Postoperative Complications

Effects of Preoperative Oral Carbohydrate Loading on Neutrophil/Lymphocyte Ratio and Postoperative Complications Following Colorectal Cancer Surgery: a Randomized Controlled Study

White blood counts with automated differential counts were analysed from peripheral venous blood samples using fluorescence flow cytometry method. The NLR value was calculated by following equation: NLR = the absolute neutrophil count (range of normality 4,0-7,0x10ᶺ9/L) / the absolute lymphocyte count (range of normality 1-3,7x10ᶺ9/L).

Delta NLR value was defined as dynamic change in NLR value from basal value to the highest measured post-surgery NLR value. Delta NLR was calculated using following equation: Delta NRL = the highest measured post-surgery NLR value - basal NLR value.

Postoperative complications were graded as follow: Grade I considered any deviation from the normal course without the need for pharmacological treatment or surgical, endoscopic and radiologic interventions. Grade II required pharmacological treatment with drugs other than such allowed for Grade I complications. Grade I and Grade II were considered minor postoperative complications. Grade III required surgical, endoscopic or radiological intervention without or with general anesthesia. Grade IV considered life-threatening complication required intensive care unit management. Grade V included death of patient. Grade III, IV and V were considered major complications.

Characteristics of postoperative complications included: overall number of complications per group, number of participants without complications per group, number of participants with complications per group, number of participants with 1 complication per group, number of participants with 2 complications per group, number of participants with \>2 complications per group and readmission rate per group within 30 days post-surgery.

Nermina Rizvanović

PhD Anesthesiology and Intensive Care Specialist

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Neoplasms

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Cola

Patients are placed on a low carbohydrate diet (\<30 grams/day) for 28 days.

Very low carbohydrate diet for a duration of four weeks.

Very low carbohydrate diet (approximately 20 grams per day)

Eugene Fine, MD

C.J. Segal-Isaacson, EdD, RD

This study is for people whose cancer:

* has resisted chemotherapy
* are taking a break from chemotherapy
* or are looking for an alternative to the toxic effects of chemotherapy

The trial is looking to see if a very low carbohydrate diet can inhibit the growth of certain cancers.

The two major goals of the RECHARGE study are to determine:

* whether a very low carbohydrate diet can help participants reduce the amount of cancer in their bodies (as measured by a PET scan at the beginning and end of the study)
* whether participants can feel well while maintaining their weight on a very low carbohydrate diet

This research study is for people with advanced cancers who decline chemotherapy or want to take a break from chemotherapy and have cancers that primarily feed on blood sugar. Examples of such cancers include metastatic breast cancer, colon cancer, cervical and uterine cancers, ovarian cancers, and many others.

The investigators' intervention consists of a 28-day diet of high protein foods such as fish, poultry, meats, eggs and cheese as well as plenty of vegetables. Participants may eat as much of the high protein foods as they wish and can eat up to two cups of vegetables per day.

Participants strictly eliminate carbohydrate-containing foods. These foods include all starches and sweets (breads, pasta, rice, potatoes, cereals, fruit, cakes, candies, soda with sugar, etc.).

You may be eligible to participate in this one month research study if you are:

* An adult with metastatic cancer (especially breast, colon, cervical, endometrial, ovarian; others may qualify) that has resisted prior attempts to treat it with courses of chemotherapy; or if you decline chemotherapy or are looking for a break, or you seek an alternative to medicines or therapies due to toxic effects.
* Your tumor has shown up on a PET scan.
* Willing to closely follow a diet and strictly limit your carbohydrate intake.

You will not be eligible to participate if you:

* Have heart or liver condition or any other disease or condition that makes it difficult or medically hazardous (determined by your doctor) for you to follow the diet recommended for this study.
* Have kidney or kidney stone disease.

Procedures:

* We will obtain a PET/CT scan to determine your eligibility if you are otherwise interested in this protocol.
* We will also obtain a second PET/CT scan at the end of the dietary trial (28 days).
* We will also obtain blood and urine tests at weekly intervals during the trial.

Visits and contacts:

* We will see you once/week for four weeks on the Albert Einstein, or Montefiore Medical Center Campus (your choice) for a total of 5 visits, and will call you on the phone at least one additional time each week. The first visit will take approximately one hour or as long as is needed to understand the diet correctly. The remaining visits will take approximately one-half hour. The PET/CT scan will take approximately 25 minutes in the camera. Waiting time varies for the procedure but is usually less than 20 minutes.

Compensation:

* Low carbohydrate supplement shakes will be given to all participants.
* All procedures and visits are without cost to the subject.
* There are no funds for direct compensation.

Description of the Intervention:

* The diet will severely restrict carbohydrates (that is, NO sugars or starches; no bread, pasta, rice, sugary drinks, potatoes or potato chips, cake, cookies, ice cream, etc).
* You will be allowed to eat AS MUCH AS YOU LIKE of foods that have very small amounts of carbohydrate, such as eggs, beef, poultry, fish, salads (except potatoes and other starchy vegetables).

The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer

Pilot Feasibility Study Of A Low Carbohydrate Diet In Patients With Advanced Cancer

Montefiore Medical Center

Albert Einstein College of Medicine

Principle Investigator

Nutritional and Metabolic Diseases

Insulin Resistance

Uterine Cervical Diseases

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Hypoglycemic Agents

Insulin

Insulin, Globin Zinc

receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery

fast on standard hospital protocol (8 hour fasting for solid and 4 hour fasting for clear liquid

patients undergoing neoadjuvant chemotherapy and radical hysterectomy with bilateral pelvic lymph node dissection were randomized to receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery

oral carbohydrate liquid

To evaluate the effects of preoperative oral carbohydrate on postoperative insulin resistance and tumor immunity in cervical cancer patients with neoadjuvant chemotherapy.

Fifty-one patients undergoing neoadjuvant chemotherapy and radical hysterectomy with bilateral pelvic lymph node dissection were randomized to receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery(CHO group) or to fast on standard hospital protocol (8 hour fasting for solid and 4 hour fasting for clear liquid)(FAST group).According to inclusion and exclusion standards, twenty-six patients undergoing the same surgery and standard fasting were selected as control group. Baseline and postoperative measurements of insulin sensitivity were assessed in term of fasting plasma glucose(FPG),fastingainsulin(FINS),HOMA-insulinaresistance(HOMA-IR),HOMA-insulin secretion function index(HOMA-IX) , HOMA-beta cell function index(HOMA-β),serum C-peptide and glucagon.Baseline and postoperative measurements of tumor immunity were evaluated using NK cell and T-cell dynamics.VAS score was introduced to assess preoperative comfort.

Effects of Anesthesia on Tumor Immunity and Insulin Resistance During Perioperative Period

Effects of Drug or Drink Intervention and Temperature Protectionon for Cervical Cancer Patients on Insulin Resistance and Tumor Immunity

The patient's insulin resistance was determined by fasting plasma glucose(FPG),fastingainsulin(FINS), andHOMA-IR=FPG（mmol/L）×FINS（mIU/L）/22.5

The patient's tumor immune level was determined by changes in T cells (CD3+、CD4+、CD8+、CD44+) and NK cells in the patient's blood

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
Soy Isoflavones and Breast Cancer Risk Reduction	NCT00204490	Breast Cancer	isoflavones carbohydrate	30 Years - 42 Years	The University of Texas Medical Branch, Galveston
Preoperative Administration of Oral Carbohydrate Drink, Neutrophil/Lymphocyte Ratio and Postoperative Complications	NCT05301985	Neutrophil Lymphocyte Postoperative C...	preoperative nu...	18 Years - 70 Years	Cantonal Hospital Zenica
The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer	NCT00444054	Cancer Breast Cancer Colon Cancer Cervical Cancer Uterine Cancer Ovarian Cancer	Very low carboh...	21 Years -	Albert Einstein College of Medicine
Effects of Anesthesia on Tumor Immunity and Insulin Resistance During Perioperative Period	NCT03872635	Anesthesia Cervical Cancer Carbohydrate Tumor Immunity	oral carbohydra...	18 Years - 70 Years	Fujian Cancer Hospital
Effects of Anesthesia on Tumor Immunity and Insulin Resistance During Perioperative Period	NCT03872635	Anesthesia Cervical Cancer Carbohydrate Tumor Immunity	oral carbohydra...	18 Years - 70 Years	Fujian Cancer Hospital
The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer	NCT00444054	Cancer Breast Cancer Colon Cancer Cervical Cancer Uterine Cancer Ovarian Cancer	Very low carboh...	21 Years -	Albert Einstein College of Medicine
Soy Isoflavones and Breast Cancer Risk Reduction	NCT00204490	Breast Cancer	isoflavones carbohydrate	30 Years - 42 Years	The University of Texas Medical Branch, Galveston

Spots Global Cancer Trial Database for carbohydrate

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