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

October 29, 2020 updated by: Eugene Fine, Albert Einstein College of Medicine

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.).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
28 day trial

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety of a very low carbohydrate diet in individuals with metastatic cancer
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

Montefiore Medical Center
Robert C. Atkins Foundation

Investigators

  • Principal Investigator: Eugene Fine, MD, Albert Einstein College Of Medicine
  • Study Director: C.J. Segal-Isaacson, EdD, RD, Albert Einstein College Of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

March 5, 2007

First Submitted That Met QC Criteria

March 5, 2007

First Posted (ESTIMATE)

March 7, 2007

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-064

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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