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
  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
Behavioral: Very low carbohydrate diet (approximately 20 grams per day)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Feasibility Study Of A Low Carbohydrate Diet In Patients With Advanced Cancer

Resource links provided by NLM:


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 ]

Enrollment: 10
Study Start Date: February 2006
Study Completion Date: May 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dietary modification
Patients are placed on a low carbohydrate diet (<30 grams/day) for 28 days.
Behavioral: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444054

Locations
United States, New York
The Albert Einstein College of Medicine of Yeshiva University
Bronx, New York, United States, 10461
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

Additional Information:
Publications:
Fine EJ, Segal-Isaacson CJ, Feinman R, Sparano J: Carbohydrate restriction in patients with advanced cancer: a protocol to assess safety and feasibility with an accompanying hypothesis. Commun Oncol 2008;5:22-26

Responsible Party: Eugene Fine, Principle Investigator, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT00444054     History of Changes
Other Study ID Numbers: 2004-064
Study First Received: March 5, 2007
Last Updated: September 24, 2012
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Uterine Cervical Neoplasms
Breast Neoplasms
Uterine Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Cervical Diseases
Uterine Diseases
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 02, 2014