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The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer (RECHARGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00444054
Recruitment Status : Completed
First Posted : March 7, 2007
Last Update Posted : September 26, 2012
Sponsor:
Collaborators:
Robert C. Atkins Foundation
Montefiore Medical Center
Information provided by (Responsible Party):
Eugene Fine, Albert Einstein College of Medicine

Tracking Information
First Submitted Date  ICMJE March 5, 2007
First Posted Date  ICMJE March 7, 2007
Last Update Posted Date September 26, 2012
Study Start Date  ICMJE February 2006
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2007)
Change in tumor FDG uptake from PET/CT imaging over a 28 period. PET is done at baseline and 28 days.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2008)
Safety of a very low carbohydrate diet in individuals with metastatic cancer [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2007)
Patient's weight and perceived quality of life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer
Official Title  ICMJE Pilot Feasibility Study Of A Low Carbohydrate Diet In Patients With Advanced Cancer
Brief Summary

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.).

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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Breast Cancer
  • Colon Cancer
  • Cervical Cancer
  • Uterine Cancer
  • Ovarian Cancer
Intervention  ICMJE Behavioral: Very low carbohydrate diet (approximately 20 grams per day)
Very low carbohydrate diet for a duration of four weeks.
Study Arms  ICMJE Experimental: Dietary modification
Patients are placed on a low carbohydrate diet (<30 grams/day) for 28 days.
Intervention: Behavioral: Very low carbohydrate diet (approximately 20 grams per day)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2007)
10
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00444054
Other Study ID Numbers  ICMJE 2004-064
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eugene Fine, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE
  • Robert C. Atkins Foundation
  • Montefiore Medical Center
Investigators  ICMJE
Principal Investigator: Eugene Fine, MD Albert Einstein College of Medicine
Study Director: C.J. Segal-Isaacson, EdD, RD Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP