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Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University Robert C. Atkins Foundation Montefiore Medical Center |
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Information provided by: | Albert Einstein College of Medicine of Yeshiva University |
ClinicalTrials.gov Identifier: | NCT00444054 |
This study is for people whose cancer:
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:
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.).
Condition | Intervention |
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Cancer Breast Cancer Colon Cancer Cervical Cancer Uterine Cancer Ovarian Cancer |
Other: Very low carbohydrate diet (approximately 20 grams per day) |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Feasibility Study Of A Low Carbohydrate Diet In Patients With Advanced Cancer |
Estimated Enrollment: | 12 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Other: Very low carbohydrate diet (approximately 20 grams per day)
Very low carbohydrate diet for a duration of four weeks.
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You may be eligible to participate in this one month research study if you are:
You will not be eligible to participate if you:
Procedures:
Visits and contacts:
Compensation:
Description of the Intervention:
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eugene Fine, MD | 718-904-2639 | efine@aecom.yu.edu |
Contact: C.J. Segal-Isaacson, EdD, RD | 718-430-2161 | isaacson@aecom.yu.edu |
United States, New York | |
The Albert Einstein College of Medicine of Yeshiva University | Recruiting |
Bronx, New York, United States, 10461 | |
Principal Investigator: Eugene Fine, MD | |
Sub-Investigator: C.J. Segal-Isaacson, EdD, RD | |
Sub-Investigator: Joseph A. Sparano, MD | |
Sub-Investigator: Richard Feinman, PhD |
Principal Investigator: | Eugene Fine, MD | Albert Einstein College of Medicine of Yeshiva University |
Study Director: | C.J. Segal-Isaacson, EdD, RD | Albert Einstein College of Medicine of Yeshiva University |
Responsible Party: | Albert Einstein College of Medicine ( Eugene J Fine, MD ) |
Study ID Numbers: | 2004-064 |
Study First Received: | March 5, 2007 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00444054 |
Health Authority: | United States: Institutional Review Board |
Diet Cancer Alternative Breast Colon Cervix |
Uterus Ovary Metastatic Nutrition Carbohydrate |
Gastrointestinal Diseases Gonadal Disorders Colonic Diseases Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasm Metastasis Uterine Neoplasms Breast Diseases Endocrine Gland Neoplasms Ovarian cancer Digestive System Neoplasms Ovarian Neoplasms |
Skin Diseases Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Uterine Diseases Intestinal Diseases Intestinal Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Endocrinopathy Colonic Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |