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CompletedNCT00444054RECHARGEUpdated Oct 30, 2020

The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer

An interventional study of Very low carbohydrate diet (approximately 20 grams per day) in Cancer, Breast Cancer and Colon Cancer, sponsored by Albert Einstein College of Medicine. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-10-30.

Sponsored by Albert Einstein College of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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.).

Read the 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).
02

Conditions studied

  • Cancer
  • Breast Cancer
  • Colon Cancer
  • Cervical Cancer
  • Uterine Cancer
  • Ovarian Cancer

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Keywords

  • Diet
  • Cancer
  • Alternative
  • Breast
  • Colon
  • Cervix
  • Uterus
  • Ovary
  • Metastatic
  • Nutrition
  • Carbohydrate
03

In context

Uterine Neoplasms

255 studies on the registry are indexed under Uterine Neoplasms; 64 are open to participants now.

This study's enrollment of 10 is below the median of 49 across 181 interventional studies indexed under Uterine Neoplasms.

Browse Uterine Neoplasms studies →

Lead sponsor

Albert Einstein College of Medicine is the lead sponsor of 199 studies on the registry; 21 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 35 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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)

Interventions

  • BehavioralVery low carbohydrate diet (approximately 20 grams per day)

    Very low carbohydrate diet for a duration of four weeks.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Safety of a very low carbohydrate diet in individuals with metastatic cancer

    Time frame: 28 days

07

Study locations

1 site
  • The Albert Einstein College of Medicine of Yeshiva University
    Bronx, New York 10461, United States
08

References and documents

Publications

  • Fine EJ, Miller A, Quadros EV, Sequeira JM, Feinman RD. Acetoacetate reduces growth and ATP concentration in cancer cell lines which over-express uncoupling protein 2. Cancer Cell Int. 2009 May 29;9:14. doi: 10.1186/1475-2867-9-14. PubMed 19480693 ↗
  • 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
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00444054
Lead sponsor
Albert Einstein College of Medicine
Collaborators
Robert C. Atkins Foundation, Montefiore Medical Center
Responsible party
Eugene Fine (Principle Investigator, Albert Einstein College of Medicine) — Principal investigator
First posted
Mar 7, 2007
Start date
Feb 2006
Primary completion
May 2010
Completion
May 2012
Last update
Oct 30, 2020

Study contacts

Eugene Fine, MD
principal investigator · Albert Einstein College of Medicine
C.J. Segal-Isaacson, EdD, RD
study director · Albert Einstein College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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