The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer

This study has been completed.
Sponsor:
Collaborators:
Robert C. Atkins Foundation
Montefiore Medical Center
Information provided by (Responsible Party):
Eugene Fine, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00444054
First received: March 5, 2007
Last updated: September 24, 2012
Last verified: September 2012

March 5, 2007
September 24, 2012
February 2006
May 2010   (final data collection date for primary outcome measure)
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 ]
Change in tumor FDG uptake from PET/CT imaging over a 28 period. PET is done at baseline and 28 days.
Complete list of historical versions of study NCT00444054 on ClinicalTrials.gov Archive Site
Safety of a very low carbohydrate diet in individuals with metastatic cancer [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Patient's weight and perceived quality of life.
Not Provided
Not Provided
 
The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer
Pilot Feasibility Study Of A Low Carbohydrate Diet In Patients With Advanced Cancer

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).
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Breast Cancer
  • Colon Cancer
  • Cervical Cancer
  • Uterine Cancer
  • Ovarian Cancer
Behavioral: Very low carbohydrate diet (approximately 20 grams per day)
Very low carbohydrate diet for a duration of four weeks.
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
May 2012
May 2010   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00444054
2004-064
Yes
Eugene Fine, Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
  • Robert C. Atkins Foundation
  • Montefiore Medical Center
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
Albert Einstein College of Medicine of Yeshiva University
September 2012

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