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The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer

NCT00444054 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-10-30

No results posted yet for this 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.).

Conditions

Interventions

BEHAVIORAL

Very low carbohydrate diet (approximately 20 grams per day)

Very low carbohydrate diet for a duration of four weeks.

Sponsors & Collaborators

  • Robert C. Atkins Foundation

    collaborator OTHER

  • Montefiore Medical Center

    collaborator OTHER

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Eugene Fine, MD · Albert Einstein College of Medicine

  • C.J. Segal-Isaacson, EdD, RD · Albert Einstein College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2010-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00444054 on ClinicalTrials.gov