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The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer
This study is currently recruiting participants.
Verified by Albert Einstein College of Medicine of Yeshiva University, November 2008
Sponsors and Collaborators: Albert Einstein College of Medicine of Yeshiva University
Robert C. Atkins Foundation
Montefiore Medical Center
Information provided by: Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT00444054
  Purpose

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.).


Condition Intervention
Cancer
Breast Cancer
Colon Cancer
Cervical Cancer
Uterine Cancer
Ovarian Cancer
Other: Very low carbohydrate diet (approximately 20 grams per day)

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Ovarian Cancer Uterine Cancer
U.S. FDA Resources
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

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Change in tumor FDG uptake from PET/CT imaging over a 28 period. PET is done at baseline and 28 days [ Time Frame: 28 day trial ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of a very low carbohydrate diet in individuals with metastatic cancer [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

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
1: Experimental Other: Very low carbohydrate diet (approximately 20 grams per day)
Very low carbohydrate diet for a duration of four weeks.

Detailed Description:

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).
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • You're an adult with metastatic cancer (breast, colon; others may qualify) that has been resistant to chemotherapy or would like a break from chemotherapy.
  • Your tumor shows up on a PET or PET/CT scan.
  • You are willing to closely follow a diet which strictly limits your carbohydrate intake (sugars, starches, etc). We will help you with nutrition counseling but you must prepare your meals, or have someone help you prepare your meals.
  • You are able to come to the Albert Einstein College of Medicine in Bronx, NY for an initial evaluation appointment and weekly nutrition counseling appointments for a four-week period.

Exclusion Criteria:

  • Have a heart condition, liver condition or any other disease or condition that makes it difficult or medically hazardous (as determined by your doctor) for you to follow the study diet.
  • Have kidney or kidney stone disease.
  • Are too thin or have lost too much weight.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444054

Contacts
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

Locations
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            
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Robert C. Atkins Foundation
Montefiore Medical Center
Investigators
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
  More Information

The RECHARGE Trial at The Albert Einstein College of Medicine  This link exits the ClinicalTrials.gov site
Faculty Profile Site for Eugene Fine, Principle Investigator  This link exits the ClinicalTrials.gov site

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

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Diet
Cancer
Alternative
Breast
Colon
Cervix
Uterus
Ovary
Metastatic
Nutrition
Carbohydrate

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009